TRIGEN™ META-NAIL™ Instruments

Surgical Technique
Including
TRIGEN™ META-NAIL™ Semi-extended Instrument Set
Surgical Technique
Table of contents
Indications............................................................................................ 2
Implant specifications............................................................................ 4
Surgical technique
Patient positioning................................................................................. 5
Incision and entry point......................................................................... 10
Entry portal acquisition ......................................................................... 11
Entry portal............................................................................................. 12
Alternative technique: Entry portal........................................................ 12
Fracture reduction.................................................................................. 14
Reducer removal.................................................................................... 14
Implant measurement............................................................................ 15
Unreamed technique............................................................................. 16
Reamed technique................................................................................. 17
Nail assembly......................................................................................... 19
Nail insertion.......................................................................................... 23
Check nail depth.................................................................................... 24
Screw insertion...................................................................................... 29
Locking screw measurement................................................................. 31
Locking screw insertion......................................................................... 31
Proximal locking: Static.......................................................................... 32
Proximal locking: Dynamic..................................................................... 32
Proximal locking: Compression ............................................................ 33
Nail extraction: Optional
Standard technique............................................................................... 35
Percutaneous technique........................................................................ 35
Guide rod jamming technique............................................................... 36
Catalog information ............................................................................ 37
Nota Bene
The technique description herein is made available to the healthcare professional to illustrate the
authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred
treatment is that which addresses the needs of the patient.
The technique is based on the tibial nailing approach outlined in the article below:
Tornetta P, 3rd, Collins E. Semiextended position of intramedullary nailing of the proximal tibia.
Clin Orthop Relat Res. 1996: Number 328, pp 185-189.
1
Indications
The TRIGEN™ META-NAIL™ Tibial Nail is indicated for fractures of the proximal
and distal third of the tibia, including the shaft, stable and unstable factures,
nonunions, malunions and for the prophylactic nailing of impending
pathological factures.
Note This technique deals with the joint space around the knee. Caution must
be taken at all times during the procedure. The Entry Tube is needed for guide
pin placement, reaming, measuring, fracture reduction, and insertion of the guide
rod. Please be aware there is a possibility of damaging the posterior aspect of the
patella and the surrounding tendons if care is not taken.
The TRIGEN META-NAIL Semi-extended Instrument Set has been designed with
these concerns in mind.
2
TRIGEN™ SURESHOT™ indications
Legend
Important warnings appear in orange
Tips, tricks and important information appear
in blue
Indications, contraindications, intended use and training
The Smith & Nephew TRIGEN™ SURESHOT™ Distal Targeting System is intended to be an
intraoperative image-guided localization system. It is a computer-assisted orthopaedic surgery
tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.
It provides information to the surgeon that is used to place surgical instruments during surgery
utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew TRIGEN
SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails
in which the use of stereotactic surgery may be appropriate.
An example of a surgical procedure includes but is not limited to locating and drilling the distal
holes in an intramedullary nail.
Contraindications
The screw targeting software application for this system is contraindicated for all IM nails other
than Smith & Nephew TriGEN META-NAIL™, TAN™, FAN, Humeral, Pediatric and Adolescent nails.
Do not operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker. The
magnetic field produced by the Targeter may interfere with the operation of the pacemaker.
Intended use
The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated
implants and instruments. Implants and instruments must be used in accordance with the
instructions, as described in this manual and/or in the non-navigated surgical procedure.
Training
Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System. The
various operating instructions must be fully read and understood as part of the training. If any part
of the instructions is unclear, please contact your local Smith & Nephew representative.
Plausibility check
As with all technical equipment, malfunctions may occur due to improper use or, more rarely,
technical failure. To reduce the risks involved with such technical malfunction the operation can
be completed using manually controlled instruments, providing the malfunction is detected
without delay.
It is, therefore, important to check the plausibility of the steps, as indicated by the system, and to
carry out verification of the software targeting, particularly when using the system for the first time.
Should there be any doubt regarding correct functioning, the targeting should be verified or a
switch made to a traditional X-Ray technique.
Refer to the SURESHOT User Manual (7118-1540) for details about the SURESHOT Distal Targeting System.
3
TRIGEN™ META-NAIL™ Tibial Nail Specifications
TriGen META-NAIL Tibia
10º
27mm
Distal end of nail (all knee and
distal tibial)
S­pecifications
(8.5mm)
TRIGEN META-NAIL Tibia
Material
TI6AL4V
TI6AL4V
Diameter
8.5mm
10, 11.5 & 13mm
Lengths
16-50cm*
16-50cm*
Nail color
Grey
Gold
Cross section
Round
Round
Proximal diameter
(driving end)
12mm
12mm (10, 11.5 dia.)
Distal diameter
(non-driving end)
8.5mm
10, 11.5 & 13mm
Smallest thru diameter
4.8mm
5.0mm
Wall thickness
1.9mm
2.3mm (10)
13mm (13 dia.)
3.0mm (11.5)
2.3mm (13)
Top view of nail
Guide bolt thread
5/16-24 UNF
5/16-24 UNF
Screw diameter
4.5mm
5.0mm
Screw color
Grey
Gold
Major diameter
4.5mm
5.0mm
Minor diameter (core)
4.0mm
4.3mm
Screw lengths
25-65mm
25-110mm
Hex size
4.7mm
4.7mm
Alternative Hex Drivers
RT Femoral & Recon
RT Femoral & Recon
7.0mm Cannulated Screw
PERI-LOC™ 4.7mm Hexdriver,
PROFIX™ 4.7mm Hexdriver
7.0mm Cannulated Screw
PERI-LOC™ Locking Screw
Alternative modes
No
No
Proximal Locking
(Driving End)
Static lock
60mm
2º
ML view
locations/orientations
17mm/45° Screw Locked w/META-Nail Cap
23mm/45° Threaded w/bushing
30mm/25° Threaded
40mm/25° Threaded
Static Locking Hole
Threaded 4.3mm minor dia.
Threaded 4.5mm minor dia.
Dimensions
Threaded 4.7mm major dia.
Threaded 5.3mm major dia.
Compression/Dynamic
10mm
10mm
4.7mm/7mm
5.3mm/7mm
10°
10°
27mm
27mm
(Non-driving End)
Static Lock Locations/
25mm/ML
25mm/ML
Orientations
15mm/AP
15mm/AP
Static Locking Hole
5mm/ML (Threaded)
4.7mm**
5mm/ML (Threaded)
5.3mm**
Degree of Distal Bend
2°
2°
Distal Bend Location
60mm
60mm
Slot Location
Non-driving end of nail
(AP view)
Compression/Dynamic
Slot Diameter/Length
Degree of Proximal
Bend (Herzog)
Note: These views are
not to scale and should
be used as a pictorial
representation only.
Proximal Bend Location
Distal Locking
Dimensions
* Set does not include all sizes.
** Most distal hole threaded.
4
Surgical Technique
Patient positioning
Position the patient supine on a radiolucent table
with the unaffected limb extended away from the
affected limb.
There should be approximately 10–20° of flexion.
Assemble the Entry Tube (7165-4526) to the
Entry Portal Handle (7167-4092) by pulling back
the black trigger of the Entry Portal Handle and
inserting the Entry Tube into the handle ring.
Turn the tube until it clicks into a locked position.
Next, place the Guide Pin Sleeve (7165-4527)
through the tube until it locks into both the end
of the sleeve and Entry Portal Handle ring.
Note Take time to inspect the Entry Tube as it
can become damaged, bent or chipped with
excessive prior reaming and insertion of other
instruments. Any flaws in the tube can lead to
damage of the surrounding tendons and tissues.
5
Warnings and cautions for TRIGEN™ SURESHOT™
Refer to the SURESHOT User Manual (7118-1540) for all warnings,
cautions, maintenance, cleaning and sterilization instructions.
Devices for system set up
TRIGEN™ SURESHOT™ Targeter
Cat. No. 7169-2801
Trauma Interface
Cat. No. 7169-2802
Power Cord
Cat. No. 6680-0193
Note The Targeter will be operated within the
sterile field and may have contact with the skin
of the patient. The drill sleeve inserts will be used
in the incision and have direct bone contact.
Note Verify that the Targeter housing is not
damaged (holes, tears, cracks). If the housing
or the connector is damaged, the Targeter is no
longer safe to use.
Note If the Targeter is not recognized after
connection to the system, the Targeter is
defective and must be exchanged. (See also
instrument connection).
Note Broken or damaged instruments must
be exchanged immediately and sent back to
Smith & Nephew, Inc.
Note This device is provided non-sterile and
must be cleaned and sterilized per Cleaning
and Sterilization (Smith & Nephew document
7138-1339) prior to use.
WARNING: The maximum temperature of the
Targeter body can reach 47° Celsius at ambient
room temperatures above 30° C. The Targeter
body should not remain in constant contact
with a patient’s exposed skin for more than
one minute.
6
Surgical procedure – OR preparation
Trauma Interface setup
After the sterile areas have been established, place the Trauma
Interface (7169-2802) in the desired non-sterile location and turn
on the power switch.
CAUTION: No other electrical devices should be placed near
the Trauma Interface. See the “Guidance and Manufacturer’s
Declaration – Separation Distances” table at the end of this
document.
Note If the Trauma Interface does not power on, make sure the
switch is in the “on” position.
Note The means for mains disconnection of power to the Trauma
Interface is the appliance inlet located below the power switch.
The Trauma Interface should not be positioned such that it is
difficult to reach this location.
TRIGEN™ SURESHOT™ Targeter connection
When the display prompts for tool connections, connect the
TRIGEN SURESHOT Targeter (7169-2801) to the Targeter port on
the Trauma Interface.
7
Surgical procedure – OR preparation
The SURESHOT™ Targeter will change color to orange upon
successful connection to the Trauma Interface.
CAUTION: The Targeter body may have contact with the
patient and must remain in the sterile field at all times. Only
the cable and connector may be removed from the sterile
field.
CAUTION: Connect the Targeter at least 10 minutes prior to
targeting in order to ensure proper accuracy.
Note When oriented as shown, the connector should
assemble easily. Do not force the connector into the port.
Note If the Targeter is properly connected to the system
and the application remains in this screen for more than
30 seconds, the Targeter may have been damaged during
cleaning/sterilization. In this case another Targeter has to be
used.
Note It is possible at any time to disconnect and reconnect
tools when the application is running. The display will show
a screen reporting the missing instrument.
8
Instruments for opening the proximal tibia
3.2mm Tip Threaded Guide Wire
Cat. No. 7163-1690
12.5mm Entry Reamer
Cat. No. 7163-1116
Entry Portal Handle
Cat. No. 7167-4092
3.2mm T-handle Trocar
Cat. No. 7167-4074
Cannulated Awl
Cat. No. 7167-4000
T-handle
Cat. No. 7167-4076
Mini Connector
Cat. No. 7163-1186
Guide Pin Sleeve
Cat. No. 7165-4527
Entry Tube
Cat. No. 7165-4526
9
Incision and entry point:
Lateral subluxation of the patella
A midline skin incision is made from the upper
pole of the patella to the middle of the patella
approximately 1.5 inches in length.
A second deep incision is made medial to the
patella, cutting the superior two-thirds of the
medial retinaculum leaving the cuff intact.
Extend the incision 1-2 cm into the quadriceps
tendon. This incision is not midline, but through
the medial one-third of the quadriceps tendon
as outlined in the image.
Sublux the patella laterally and pass the fully
assembled entry tube through the skin incision
until it is sitting on the tibial plateau.
10
Entry portal acquisition
Use the femoral condyles as a guide for proper
tube placement making sure the Guide Pin
Sleeve sits properly as outlined below.
The entry point is located just medial to the
lateral tibial eminence in the AP view and in line
with the anterior cortex and intramedullary canal
in the lateral view.
Attach the 3.2mm Tip Threaded Guide Wire
(7163-1690) to the drill via the Mini Connector
(7163-1186) and insert into the Guide Pin Sleeve.
11
Entry portal
After definitive guide wire placement, remove
the Guide Pin Sleeve and carefully slide the
Entry Tube down and onto the tibial plateau.
Attach the 12.5mm Entry Reamer (7163-1116) to
power. Advance over the guide wire through
the Entry Tube to a depth of 4–6cm in the tibia.
Maintain alignment so as to avoid penetration
of the posterior cortex.
Check position via radiographic imaging and
then remove the 12.5mm Entry Reamer and
3.2mm Tip Threaded Guide Wire.
Alternative technique: Entry portal
With the Entry Tube and Entry Portal Handle
still in the joint space, attach the T-handle
(7167-4076) to the Cannulated Awl (7167-4000)
and insert into the proximal tibia to a depth of
4–6cm. Introduce the 3.2mm T-handle Trocar
(7167-4074) into the back of the assembly prior
to insertion in order to prevent awl slippage
and accumulation of cortical bone within
the cannulation.
T-handle
Cat. No. 7167-4076
Entry Portal Handle
Cat. No. 7167-4092
3.2mm T-handle Trocar
Cat. No. 7167-4074
Cannulated Awl
Cat. No. 7167-4000
12
Entry Tube
Cat. No. 7165-4526
Instruments for fracture reduction and reaming
Entry Tube
Cat. No. 7165-4526
Entry Portal Handle
Cat. No. 7167-4092
Ruler
Cat. No. 7167-4079
T-handle
Cat. No. 7167-4076
Gripper
Cat. No. 7167-4080
Reamer Heads
Cat. No. 7111-8231–8246
3.0mm x 1000mm Ball Tip Guide Rod
Cat. No. 7163-1626
Obturator
Cat. No. 7167-4078
Flexible Reamer Shaft
Cat. No. 7111-8200
Reducer
Cat. No. 7167-4077
13
Fracture reduction
Insert the back end of the 3.0mm Ball Tip Guide
(7163-1626) into the front of the Gripper
(7167-4080) and gently close the trigger grip.
Connect the Reducer and Reducer Connector
(7167-4077) so that the words “Slot Orientation”
are in line with the opening at the tip. Complete
the assembly by connecting it to the T-handle
(7167-4076).
Advance the Reducer into the intramedullary
canal and use the curved tip to direct the
3.0mm Ball Tip Guide Rod past the fracture into
the region of the distal epiphyseal scar. The
guide rod should be center-center in the AP
and lateral views.
Reducer removal
Once the guide rod is at the desired depth,
detach the Gripper and remove the Reducer
from the tibial canal. Slide the Obturator
(7167-4078) into the back of the T-handle during
extraction in order to maintain guide rod position
within the canal.
14
Implant measurement
After Reducer removal, reconfirm guide rod
placement within the distal tibia and slide the
Ruler (7167- 4079) over the guide rod, inside the
Entry Tube, to the desired depth. The metal tip of
the Ruler denotes the driving end of the nail.
Confirm guide rod position in the window at the
opposite end of the Ruler as shown in order
to ensure accurate implant measurement.
Push down on the top of the Ruler until contact
is made with the 3.0mm Ball Tip Guide Rod.
Implant length is read from the exposed
calibrations at the end of the Ruler.
Note Confirm fracture reduction so as not to
underestimate correct implant length. Reference
the fibula for accurate fracture distraction
or compression.
Note Confirm that the Ruler opens easily. Adjust
the thumb-wheel connection at the end to allow
for free movement.
15
Unreamed technique
Radiographic templating is used to determine
nail size. The appropriate diameter implant will
provide translational till within the isthmus of
the intramedullary canal. Generally, selection
of a nail approximately 1–1.5mm less than
the narrowest canal measurement on the
lateral radiograph assists in avoiding implant
incarceration during insertion.
Note The 8.5mm diameter of the Reducer
provides an initial “sound” for determining canal
width in small diameter tibias.
TRIGEN™ META-NAIL™ Tibial Nail Radiographic Template
Cat. No. 7118-0810
16
Reamed technique
Radiographic templating and intraoperative
measurement will determine nail size.
Beginning with the 9.0mm End Cutting Reamer
Head (7111-8231) and Flexible Reamer Shaft
(7111-8200), ream the intramedullary canal
sequentially in half millimeter increments to a
size 1-1.5mm larger than the selected nail size.
Ensure Guide Rod placement during reaming
by inserting the Obturator into the back of
the Reamer unit during retraction. Continue
to confirm Guide Rod placement in the distal
tibia throughout reaming. Periodically move
the reamer back and forth in the canal to clear
debris from the cutting flutes.
17
Instruments for nail assembly and insertion
META-NAIL™ Anterior Drop
Cat. No. 7165-4501
Guide Bolt Wrench
Cat. No. 7163-1140
Semi-extended Drill Guide
Cat. No. 7165-4524
Semi-extended Guide Bolt
Cat. No. 7165-4525
9.0mm Drill Sleeve
Cat. No. 7163-1152
4.0mm Drill Sleeve
Cat. No. 7167-4083
Impactor
Cat. No. 7167-5081
4.0mm Long Pilot Drill
Cat. No. 7163-1110
Cannulated Impactor-Short
Cat. No. 7165-4554
Slotted Hammer
Cat. No. 7167-4082
META-NAIL Semi-Extended Drill Guide Probe
Cat. No. 7169-2803
T-handle
Cat. No. 7167-4076
META Set Stop
Cat. No. 7169-2806
18
Nail assembly
Attach the META-NAIL™ Semi-extended Drill
Guide (7165-4524) to the nail with the Guide
Bolt (7165-4525) and tighten with the Guide Bolt
Wrench (7163-1140) and T-handle. The nail is
correctly aligned when:
1 The
line on the insertion barrel matches the line
of the nail.
2The
“A” on the nail matches the “A” on the
insertion barrel.
3The
apex of the nail’s proximal Herzog Bend
faces posterior and the drill guide is
oriented anterior.
The bevel on the front of the nail marks the
connection to the drill guide and can be seen
in the lateral view as a means for determining
proximal insertion depth.
Attach the Anterior Drop (7165-4501) to the
drill guide and verify targeting accuracy by
inserting a gold 9.0mm Drill Sleeve (7163-1152)
and silver 4.0mm Drill Sleeve (7167-4083) into
the drop and passing a 4.0mm Long Pilot Drill
(7163-1110) through the assembly. An incorrectly
attached nail will not target.
Note Refer to SURESHOT™ User Manual for the
field accuracy check instructions.
19
Surgical procedure –
after IM Nail Assembly to the Drill Guide
Probe selection and assembly
Probe connection
Assemble the appropriate probe and set the stop for the
the TRIGEN™ IM Nail and Drill Guide that will be used.
Connect the probe to either of the probe sensor ports
on the Trauma Interface.
CAUTION: Proper orientation of the probe to the set
stop as shown is required. Failure to do so may result
in inaccurate targeting.
TRIGEN SURESHOT™
META-NAIL™
Semi-extended
Drill Guide Probe
(7169-2803)
For META-NAIL, notches
should face anteriorly
Confirm that the tool connection has been verified.
Blue probe
Use only with
META-NAIL Semiextended Drill Guide
(7169-2803)
Set the probe to the length of the TRIGEN IM Nail.
Note When oriented as shown, the connector should
assemble easily. Do not force the connector into the
port. Simply try rotating the connector until the keys are
oriented in the 12 o’clock position.
Note If the probe is properly connected to the system
and the application reports “Probe not found” for
more than 10 seconds, the probe may be damaged or
defective. In this case, the probe has to be exchanged.
Note It is possible at any time to disconnect and
reconnect tools when the application is running. The
display will show a screen reporting the missing
instrument.
20
Surgical procedure –
after IM Nail Assembly to the Drill Guide
Drill sleeve selection
Select the length of the drill sleeve (7169-2804,
7169-2805, or 7169-1165 and 7169-1166) that will
be used.
A different sleeve can be selected at any time
during the procedure by choosing the drill sleeve
option from the drop down menu OR by pressing
the drill sleeve tab located in the lower right corner
of the navigation screen.
Implant selection screen
Select the TRIGEN™ IM Nail and size that will be
used.
META-NAIL™
Note A different TRIGEN IM Nail and/or size can
be selected at any time during the procedure by
choosing the Implant option from the drop down
menu OR by pressing the implant tab located in
the lower left corner of the navigation screen.
21
Surgical procedure –
after IM Nail Assembly to the Drill Guide
Drill sleeve attachment
Tightly secure the selected drill sleeve to the Targeter.
Note The short, long, and long combo drill
sleeves (7169-2805, 7169-2804, and 7169-1166)
can be loosened from the Targeter using the slot
in the TRIGEN™ Hammer (7167-4082).
22
Nail insertion
Remove Entry Tube and Handle
Remove the Anterior Drop and attach the
Cannulated Impactor-Medium (7167-5081) to the
drill guide. Orient the drill guide assembly in the
AP position and advance the nail over the guide
rod by light blows from the Slotted Hammer
(7167-4082) to the desired depth.
Additional reaming of the intramedullary canal
may be indicated if excessive force is required
to insert the nail.
Verify fracture reduction as the nail crosses the
fracture site by paying close attention to rotation,
length, alignment, distraction and/or shortening.
Check final nail position in both the AP and
lateral views for correct alignment.
Tip Provisional fixation of the proximal tibial
fragments may be obtained by reattaching the
Anterior Drop and by inserting the gold 9.0mm
Drill Sleeve (7163-1152) and silver 4.0mm Drill
Sleeve (7167-4083) into one of the two Blocking
Screw holes in the Drop and passing a 4.0mm
Long Pilot Drill (7163-1110)*.
* 4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
23
Check nail depth
Proximal
In the lateral view, confirm nail position by
observing the notch present at the nail/drill
guide junction. If compression or dynamic
locking is desired, it is recommended to
countersink the nail approximately 10mm to
avoid implant prominence.
Distal
In the AP and lateral views, confirm that the nail
has been inserted to the desired depth. Distal
third tibial fractures require at least three locking
screws to maintain stability, so optimal insertion
depth is essential. Remove the Guide Rod once
the nail has been fully seated and attach the
Anterior Drop.
Note Following nail insertion, confirm that the
nail and drill guide are securely connected as
hammering can loosen the Guide Bolt.
Tip For additional confirmation of the proximal
location of the nail, take the 3.2mm Guide Pin
and place under the base of the drill guide
where the drop would be connected and press
to skin. The base of the drill guide and end of
the nail are in line.
With the Guide Pin in position, take a lateral
radiograph. This will give you a good idea of
the location.
24
Items to target and drill distal holes
TRIGEN™ SURESHOT™ Targeter
Cat. No. 7169-2801
Trauma Interface
Cat. No. 7169-2802
Power Cord
Cat. No. 6680-0193
AO Drill Bit, Short
Cat. No. 7169-2810
AO Drill Bit, Long
Cat. No. 7169-2811
Inner Drill Sleeve, Long
Cat. No. 7169-1165
Outer Screw Sleeve, Long
Cat. No. 7169-1166
META-NAIL™ Semi-Extended Drill Guide Probe
Cat. No. 7169-2803
Drill Sleeve, Long
Cat. No. 7169-2804
Drill Sleeve, Short
Cat. No. 7169-2805
META Set Stop
Cat. No. 7169-2806
Note When the targeter is out of the preferred
range or there is metal or electrical interference,
the green and red targeter circles on the
Trauma Interface screen may become unstable
and/or a warning message will be displayed. If
the interference is excessive, the IM nail image
on the Trauma Interface screen will disappear. If
interference cannot be avoided, a standard
X-Ray technique must be used.
Note All tool cables should be uncoiled
completely and any excess cables should be
kept out of the targeter measurement volume.
25
Detach Cannulated Impactor-Medium (7167-5081) from
drill guide. Reattach META Set Stop (7169-2806) and insert
META-NAIL™ Standard Drill Guide Probe (7169-2814) in the
nail. Adjust probe to nail length.
Skin incision
Use serrated tip of Drill Sleeve to identify where
to make incision. The tip is at the right position
when the green circle is aligned with the desired
hole on screen.
Make incision and place tip of the drill sleeve
down to bone where the green circle is aligned
directly over the hole on screen.
Note No X-Rays necessary.
26
Targeting the locking hole
With the appropriate length TRIGEN™ SURESHOT™
4.0mm Drill Bit (7169-2810 or 7169-2811) inserted
into the targeter, insert the tip of the drill sleeve
(represented by the green circle) through the
incision and down to bone.
Critical Verify there are no other metal
objects (including metal triangles) in the field.
Metal interference will cause the system to
be inaccurate.
Perfect circles
Align the tip of the drill sleeve over the desired
hole in the nail. This will be represented on
the screen when the green circle is centered
in the hole as shown. Push serrated tip firmly
against bone to keep the green circle static on
the screen.
Adjust the trajectory (represented by red line
between two circles) of the red circle until both
circles are concentric and centered with the
desired hole on the screen. Then start drilling.
Note The green ring must be fully within the hole
of the IM nail displayed on the Trauma Interface
screen to ensure accurate drilling.
27
Drilling distal hole
Drill through near cortex and the nail using the
TRIGEN™ SURESHOT™ 4.0mm Drill Bit (7169-2810
or 7169-2811). Before drilling through far cortex,
obtain the screw measurement.
Note Important: if standard 4.0mm drill from
trigen set is used, magnetic metal can
adversely affect accuracy causing the drill to
miss. Verify there is no other magnetic metal
object in area other than the items shown.
A note will appear on screen warning of
compromised targeting field, if magnetic metal
is close. If it is in the field, image disappears.
Drill Depth Measurement
Refer to User Manual Page 16 and 17 for drill
depth measurements.
28
Screw insertion
Using the TRIGEN™ SURESHOT™ Hexdriver
(7169-2809), the screw may be inserted
using the Targeter.
WARNING The standard TRIGEN Hexdrivers are
made from magnetic stainless steel that will
cause interference with the system and cannot
be used.
Using the Combo Drill Sleeve
TRIGEN SURESHOT Inner Drill Sleeve, Long
Cat. No. (7169-1165)
TRIGEN SURESHOT Outer Screw Sleeve, Long
Cat. No. (7169-1166)
1. While holding the Targeter to bone, remove
the SURESHOT Inner Drill Sleeve-Long
(7169-1165) from the SURESHOT Outer Screw
Sleeve-Long (7169-1166).
2. Use the TRIGEN SURESHOT Hexdriver
(7169-2809) to insert the appropriate length
screw through the SURESHOT Outer Screw
Sleeve-Long.
3. When screw insertion is complete, remove the
probe from the IM nail.
29
Instruments for standard, dynamic and compression locking
Nail Cap Set Screw
Cat. No. 7165-6000
Screw Length Sleeve
Cat. No. 7167-4085
META-NAIL™ Anterior Drop
Cat. No. 7165-4501
Medium Hexdriver
Cat. No. 7163-1066
Mini Connector
Cat. No. 7163-1186
4.0mm Drill Sleeve
Cat. No. 7167-4083
Universal META-NAIL Compression Driver
Cat. No. 7165-4528
9.0mm Drill Sleeve
Cat. No. 7163-1152
Screw Depth Gauge
Cat. No. 7163-1189
4.0mm Long Pilot Drill*
Cat. No. 7163-1110
T-handle
Cat. No. 7167-4076
4.0mm Short Drill**
Cat. No. 7163-1117
Screwdriver Release
Cat. No. 7167-4084
* 4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
** 4.0mm Short Drill (7163-1117) is interchangeable with 4.0mm AO Short Drill (7163-1123)
30
Locking screw measurement
1
There are three methods:
1
Gold 9.0mm Drill Sleeve, silver 4.0mm Drill
Sleeve and 4.0mm Long Pilot Drill*.
2 Screw
Depth Gauge (7163-1189).
3 Screw
Length Sleeve (7167-4085) and 4.0mm
Short Drill (7163-1117)**.
2
3
Locking screw insertion
Proximal locking options include three statically
locked threaded holes and one slot that
allows for both fracture compression and/
or dynamization. These are targeted through
the orange and blue color-coded holes on the
Anterior Drop.
Distal locking options include three statically
locked holes, two ML and one AP.
The most distal ML hole is threaded for
additional stability.
Gold 5.0mm locking screws are compatible
with 10mm, 11.5mm and 13mm diameter nails
and grey 4.5mm locking screws with 8.5mm
diameter nails.
Final image of the META-NAIL™ Tibial
Nail with all four proximal screws
inserted.
Note Do not use the 4.0mm Short Step Drill
(7164-1123) when drilling for a grey 4.5mm
locking screw. Its diameter transitions from
4.0mm to 4.7mm and will drill too large a hole in
the near cortex. This may compromise locking
screw purchase.
*4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
**4.0mm Short Drill (7163-1117) is interchangeable with 4.0mm AO Short Drill (7163-1123)
31
Note Make sure to remove probe before
proximal locking.
Proximal locking: Static
Make a small incision at the site of screw entry
and insert the gold 9.0mm Drill Sleeve and silver
4.0mm Drill Sleeve through the static slot on the
Anterior Drop down to bone. Drill both cortices
with the 4.0mm Long Pilot Drill*.
Measure for screw length using either the
calibrations on the 4.0mm Long Pilot Drill* or
by removing the 4.0mm Drill Sleeve and using
the Screw Depth Gauge. Attach the appropriate
length screw to the end of the Medium
Hexdriver (7163-1066) and insert through the
gold 9.0mm Drill Sleeve on power until the laser
etched ring on the Hexdriver reaches the back
of the drill sleeve. Attach the T-handle to the
Hexdriver and tighten the screw by hand.
Proximal locking: Dynamic
With the nail countersunk approximately 10mm,
make a small incision at the site of screw entry
and insert the gold 9.0mm Drill Sleeve and
silver 4.0mm Drill Sleeve through the dynamic
slot on the Anterior Drop down to bone. Drill
both cortices with the 4.0mm Long Pilot Drill*.
Screw measurement and insertion follows the
previously described technique.
Note Use the “TIBIA” and “ALL NAILS” holes
marked on the META-NAIL™ drop.
Note If nail is left in dynamic mode, a nail cap
cannot be used, as it will push against the
locking screw.
* 4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
32
Proximal locking: Compression
There are two (2) methods:
Compression Driver method
1
Countersink the nail a minimum of 10mm and
lock the nail distally.
2 Reduce
the fracture as much as possible
to maximize the advantage of the
compression driver.
3 Insert
a screw through the proximal side of
dynamic slot as previously described.
4 Remove
the gold 9.0mm Drill Sleeve and
Medium Hexdriver.
5 Attach
the Universal Compression Driver (71654528) to the T-handle and thread it through the
guide bolt into the top of the nail until it contacts
the most proximal 5.0mm locking screw.
6 Advance
the Compression Driver clockwise
to drive the locking screw distally which will
compress the fracture up to 7mm.
7 Once
the fracture gap is adequately
compressed, lock the nail with up to three
additional proximal static screws while the
Anterior Drop is still attached to the drill guide.
Nail Cap Set Screw method
Lock the nail distally, fully insert the dynamic
locking screw as previously described and
remove the Drill Guide/Anterior Drop assembly.
Insert the Nail Cap Set Screw (7165-6000) into
the top of the nail and advance with the Medium
Hexdriver/T-handle assembly until the fracture
is compressed and the Nail Cap Set Screw has
fully engaged the locking screw.
Note If the Compression Driver is progressed
after the fracture is fully compressed, then the
locking screw will begin to bend. In extreme
cases where excess force is applied, the screw
may break upon removal.
Note For additional information on Blocking
Screws, reference the TRIGEN™ META-NAIL™ Tibial
Nail Surgical Technique.
33
Instruments for implant removal
3.2mm Tip Threaded Guide Wire
Cat. No. 7163-1690
12.5mm Entry Reamer
Cat. No. 7163-1116
Mini Connector
Cat. No. 7163-1186
Disposable Nail Extractor***
Cat. No. 7163-1320
Cannulated Impactor-Medium
Cat. No. 7167-5081
Cannulated Impactor-Long**
Cat. No. 7163-1185
3.0mm x 1000mm Ball Tip Guide Rod*
Cat. No. 7163-1626
Slotted Hammer
Cat. No. 7167-4082
T-handle
Cat. No. 7167-4076
Medium Hexdriver
Cat. No. 7163-1066
* Additional Guide rods listed on page 46
** The Cannulated Impactor-Long is located in the original TRIGEN™ Instrument Set (7163-1326)
***The Disposable Nail Extractor (7163-1320) is interchangeable with the Large Nail Extractor (7163-1278) located in the original
TRIGEN Instrument Set (7163-1326) and the HFN™ Instrument Set (7170-0001)
34
Nail extraction: optional
Standard technique
Remove the Nail Cap or Nail Cap Set Screw if
implanted and all of the distal locking screws
with the Medium Hexdriver/T-Handle assembly.
Remove all of the proximal locking screws
except for one in the same manner.
Thread the Cannulated Impactor-Medium
(7167-5081) or Cannulated Impactor-Long
(7163-1185)* into the back of the Disposable
Nail Extractor (7163-1320)** and then thread
the assembly into the top of the nail. Remove
the remaining proximal locking screw and then
extract the nail with a back-slapping motion
using the Slotted Hammer.
Percutaneous technique
This technique assumes the absence of a Nail
Cap or Nail Cap Set Screw. Remove all distal
locking screws and all but one of the proximal
locking screws as previously described. Under
fluoroscopy, insert a 3.2mm Tip Threaded Guide
Wire (7163-1690) into the top of the nail on
power or by hand. Make a 2cm incision around
the pin and advance the 12.5mm Entry Reamer
over the pin and into the top of the nail to
remove any bony ingrowth.
Thread the Cannulated Impactor-Medium or
Cannulated Impactor-Long* (7163-1185) into
the back of the Disposable Nail Extractor**
(7163-1320) and then thread the assembly
into the top of the nail. Remove the remaining
proximal locking screw and then extract the
nail with a back-slapping motion.
Note The tip of the Entry Reamer is straight for
approximately 1cm before flaring out. It is this
portion of the Entry Reamer that enters the top
of the nail.
* The Cannulated Impactor-Long is located in the original TRIGEN™ Instrument Set (7163-1326)
**The Disposable Nail Extractor (7163-1320) is interchangeable with the Large Nail Extractor located in the original TRIGEN™
Instrument Set (7163-1326) and the HFN™ Instrument Set (7170-0001)
35
An alternative method
for extraction
Guide rod jamming technique
Advance the end of a 3.0mm Ball Tip Guide
Rod through the end of the nail. Insert a 2.0mm
Smooth Guide Rod (7111-8280) in the same
manner. With both guide rods in place, attach
the Gripper to the end of the 3.0mm Ball Tip
Guide Rod and pull it back so that it wedges the
ball tip against the 2.0mm Smooth Guide Rod.
Backslap against the Gripper with the Slotted
Hammer to extract the nail.
Guide rods
Cat. No.
Description
7111-8280
2.0mm x 900mm Smooth
(Russell-Taylor™ System)*
7111-8202
3.0mm x 900mm Ball Tip
(Russell-Taylor System)*
7163-1626 3.0mm x 1000mm Ball Tip
(TRIGEN™ System)
Additional removal items
Cat. No.
Description
115074
Large Extractor Hook*
115073
Small Extractor Hook*
914658
Large Easy Out**
914659
Small Easy Out**
* Available sterile packed. For nail removal only, do not use for nail insertion
** Located in Russell-Taylor Extraction Kit (Set #7508) available through Loaners
36
Catalog information – TRIGEN™ META-NAIL™ Implants
TRIGEN Internal Captured Screws 4.5mm and 5.0mm
Set No. 7163-1321 Cat. No.
Length
Cat. No.
Length
7164-2125
4.5mm x 25mm
7164-2225
5.0mm x 25mm
7164-2130
4.5mm x 30mm
7164-2230
5.0mm x 30mm
7164-2135
4.5mm x 35mm
7164-2235
5.0mm x 35mm
7164-2140
4.5mm x 40mm
7164-2240
5.0mm x 40mm
7164-2145
4.5mm x 45mm
7164-2245
5.0mm x 45mm
7164-2150
4.5mm x 50mm
7164-2250
5.0mm x 50mm
7164-2255
5.0mm x 55mm
7164-2260
5.0mm x 60mm
7164-2265
5.0mm x 65mm
7164-2270
5.0mm x 70mm
7164-2275
5.0mm x 75mm
4.5mm
5.0mm
TRIGEN META-NAIL 8.5mm Tibial
Set No. 7165-3002
Cat. No.
Length
Cat. No.
Length
7165-5024*
24cm
7165-5035*
35cm
7165-5026*
26cm
7165-5036*
36cm
7165-5028*
28cm
7165-5037*
37cm
7165-5029
29cm
7165-5038*
38cm
7165-5030*
30cm
7165-5039
39cm
7165-5031
31cm
7165-5040
40cm
7165-5032*
32cm
7165-5041
41cm
7165-5033*
33cm
7165-5042
42cm
7165-5034*
34cm
*Contained in the standard implant set
37
Catalog information – TRIGEN™ META-NAIL™ Implants
TRIGEN META-NAIL 10mm Tibial
Set No. 7165-3000
Cat. No.
Length
Cat. No.
Length
7165-5124
24cm
7165-5135*
35cm
7165-5126
26cm
7165-5136*
36cm
7165-5128*
28cm
7165-5137*
37cm
7165-5129
29cm
7165-5138*
38cm
7165-5130*
30cm
7165-5139*
39cm
7165-5131
31cm
7165-5140*
40cm
7165-5132*
32cm
7165-5141
41cm
7165-5133
33cm
7165-5142
42cm
7165-5134*
34cm
TRIGEN META-NAIL 11.5mm Tibial
Set No. 7165-3001
Cat. No.
Length
Cat. No.
Length
7165-5224
24cm
7165-5235*
35cm
7165-5226
26cm
7165-5236*
36cm
7165-5228
28cm
7165-5237*
37cm
7165-5229
29cm
7165-5238*
38cm
7165-5230*
30cm
7165-5239*
39cm
7165-5231
31cm
7165-5240*
40cm
7165-5232*
32cm
7165-5241
41cm
7165-5233
33cm
7165-5242
42cm
7165-5234*
34cm
* Contained in the standard implant set
38
TRIGEN™ META-NAIL™ 13mm Tibial
Cat. No.
Length
Cat. No.
Length
7165-5318
7165-5320
18cm
20cm
7165-5335
35cm
7165-5336
36cm
7165-5322
22cm
7165-5337
37cm
7165-5324
24cm
7165-5338
38cm
7165-5326
26cm
7165-5339
39cm
7165-5328
28cm
7165-5340
40cm
7165-5329
29cm
7165-5341
41cm
7165-5330
30cm
7165-5342
42cm
7165-5331
31cm
7165-5343
43cm
7165-5332
32cm
7165-5344
44cm
7165-5333
33cm
7165-5346
46cm
7165-5334
34cm
7165-5348
48cm
7165-5350
50cm
Nail Cap Set Screw
Cat. No. 7165-6000
TRIGEN Nail Caps
Cat. No.
Length
Cat. No.
Length
7163-4000
0mm
7163-4015
15mm
7163-4005
5mm
7163-4020
20mm
7163-4010
10mm
39
Catalog Information – TRIGEN™ META-NAIL™ Instruments
TRIGEN META-NAIL Blocking Screw Instruments
Set No. 7165-4001
Blocking Screw Device
Cat. No. 7165-4515
Tibial Blocking Screw Attachment
Cat. No. 7165-4509
11.0mm T-handle Awl
Cat. No. 7165-4522
8.5mm/10mm Blocking Screw Cartridge
Cat. No. 7165-4511
11.5mm/13mm Blocking Screw Cartridge
Cat. No. 7165-4513
Offset Blocking Screw Cartridge
Cat. No. 7165-4514
Blocking Screw Alignment Pin
Cat. No. 7165-4523
Blocking Screw Instrument Case
Cat. No. 7165-4552
Blocking Screw Instrument Lid
Cat. No. 7165-4553
40
Instruments used if you have TRIGEN™ Base Set
Set No. 7167-4012
Medium Hexdriver
Cat. No. 7163-1066
Short Hexdriver
Cat. No. 7163-1068
12.5mm Entry Reamer
Cat. No. 7163-1116
Guide Bolt Wrench
Cat. No. 7163-1140
9.0mm Drill Sleeve
Cat. No. 7163-1152
Multipurpose Driver
Cat. No. 7163-1161
Mini Connector
Cat. No. 7163-1186
Screw Depth Gauge
Cat. No. 7163-1189
Cannulated Awl
Cat. No. 7167-4000
Entry Portal Tube
Cat. No. 7167-4060
3.2mm T-handle Trocar
Cat. No. 7167-4074
Honeycomb
Cat. No. 7167-4075
Flexible Reamer Shaft
Cat. No. 7111-8200
Reamer Heads
Cat. No. 7111-8231-8246
41
T-handle
Cat. No. 7167-4076
Reducer
Cat. No. 7167-4077
Obturator
Cat. No. 7167-4078
Ruler
Cat. No. 7167-4079
Gripper
Cat. No. 7167-4080
Cannulated Impactor-Medium
Cat. No. 7167-5081
Slotted Hammer
Cat. No. 7167-4082
4.0mm Drill Sleeve
Cat. No. 7167-4083
Screwdriver Release
Cat. No. 7167-4084
Screw Length Sleeve
Cat. No. 7167-4085
Entry Portal Handle
Cat. No. 7167-4092
42
Instruments used if you have existing TRIGEN™ set
Set No. 7163-1326
Medium Hexdriver
Cat. No. 7163-1066
Short Hexdriver
Cat. No. 7163-1068
Gripper
Cat. No. 7163-1100
Entry Tool
Cat. No. 7163-1114
12.5mm Entry Reamer
Cat. No. 7163-1116
Obturator
Cat. No. 7163-1122
Reducer
Cat. No. 7163-1124
Ruler
Cat. No. 7163-1128
Guide Bolt Wrench
Cat. No. 7163-1140
Hammer
Cat. No. 7163-1150
9.0mm Drill Sleeve
Cat. No. 7163-1152
4.0mm Drill Sleeve
Cat. No. 7163-1156
Multipurpose Driver
Cat. No. 7163-1161
T-handle
Cat. No. 7163-1172
43
Catalog information – TRIGEN™ META-NAIL™ Instruments
Mini Connector
Cat. No. 7163-1186
Screw Depth Gauge
Cat. No. 7163-1189
Screw Driver Release Handle
Cat. No. 7163-1208
Cannulated Impactor-Long
Cat. No. 7163-1185
Flexible Reamer Shaft
Cat. No. 7163-1192
Reamer Heads
Cat. No. 7111-8231-8242
META-NAIL Disposables
Set No. 7165-4003
4.0mm Long Pilot Drill*
Cat. No. 7163-1110
4.0mm Short Drill**
Cat. No. 7163-1117
3.0mm x 1000mm Ball Tip Guide Rod
Cat. No. 7163-1626
3.2mm Tip Threaded Guide Wire
Cat. No. 7163-1690
Universal Compression Driver
Cat. No. 7165-4528
Disposable Nail Extractor***
Cat. No. 7163-1320
*4.0mm Long Pilot Drill (7163-1110) is interchangeable with 4.0mm AO Long Drill (7163-1121)
**4.0mm Short Drill (7163-1117) is interchangeable with 4.0mm AO Short Drill (7163-1123)
***The Disposable Nail Extractor (7163-1320) is interchangeable with the Large Nail Extractor (7163-1278) located in the original
TRIGEN Instrument Set (7163-1326) and the HFN™ Instrument Set (7170-0001)
44
Catalog information – TRIGEN™ SURESHOT™ Instruments
TRIGEN SURESHOT Targeting Interface
Cat. No. 7165-7000
Cat. No.
Device
Case Qty
7169-2802
Trauma Interface
1
TRIGEN SURESHOT Targeting Instrument Set
Set No. 7165-7001
Cat. No.
Description
Tray Qty
7169-2801
Targeter
1
7169-2804
Drill Sleeve - Long
2
7169-2805
Drill Sleeve - Short
2
7169-2806
META Set Stop
1
7169-2807
TAN™ Set Stop
1
7169-2808
Field Accuracy Gauge
1
7169-2809
Hexdriver
1
7169-2816
TAN Anteversion Locking Guide
1
7169-2830
Targeting Instrument Tray
1
7169-2831
Targeting Instrument Tray Lid
1
Other TRIGEN SURESHOT Instruments
Cat. No.
Description
Qty
7169-1165
Inner Drill Sleeve, Long
1
7169-1166
Outer Screw Sleeve, Long
1
TRIGEN SURESHOT Targeting Disposables Set
Set No. 7165-7002
Cat. No.
Description
Qty
7169-2810
AO Drill Bit, Short
2
7169-2811
AO Drill Bit, Long
1
Additional Disposables
Cat. No.
Device
7169-2803
META-NAIL™ Semi-Extended Drill Guide Probe
(used with TRIGEN META-NAIL Nail Instrument Set,
7165-4002)
45
Catalog information – TRIGEN™ SURESHOT™ Instruments
TRIGEN SURESHOT Country Kit – North America
Cat. No. 7165-7003
Cat. No.
Description
Qty
6680-0193
Power Cord, 125 Volt 10 Amp – North
America (Hospital Grade)
1
7118-1540
User Manual, English
1
Additional country kits
TRIGEN SURESHOT Country Kit – Australia
Cat. No. 7165-7004
Cat. No.
Description
Qty
6680-0303
Power Cord, 250 Volt 10 Amp –
Australia/NZ
1
7118-1540
User Manual, English
1
TRIGEN SURESHOT Country Kit – Continental
Europe
Cat. No. 7165-7005
Cat. No.
Description
Qty
6680-0291
Power Cord, 250 Volt 10 Amp –
Continental Europe
1
7118-1540
User Manual, English
1
TRIGEN SURESHOT Country Kit – Germany
Cat. No. 7165-7006
Cat. No.
Description
Qty
6680-0291
Power Cord, 250 Volt 10 Amp –
Continental Europe
1
7118-1538
User Manual, German
1
TRIGEN SURESHOT Country Kit – Spain
Cat. No. 7165-7007
Cat. No.
Description
Qty
6680-0291
Power Cord, 250 Volt 10 Amp –
Continental Europe
1
7118-1539
User Manual, Spanish
1
46
TRIGEN™ SURESHOT™ Country Kit – France
Cat. No. 7165-7008
Cat. No.
Description
Qty
6680-0291
Power Cord, 250 Volt 10 Amp –
Continental Europe
1
7118-1537
User Manual, French
1
TRIGEN SURESHOT Country Kit – Italy
Cat. No. 7165-7009
Cat. No.
Description
Qty
6680-0291
Power Cord, 250 Volt 10 Amp –
Continental Europe
1
7118-1536
User Manual, Italian
1
TRIGEN SURESHOT Country Kit – United Kingdom
Cat. No. 7165-7011
Cat. No.
Description
Qty
6680-0213
Power Cord, 250 Volt 10 Amp – UK
1
7118-1540
User Manual, English
1
TRIGEN SURESHOT Country Kit –
South Africa/India
Cat. No. 7165-7012
Cat. No.
Description
Qty
6680-0302
Power Cord, 250 Volt 10 Amp –
So. Africa/India
1
7118-1540
User Manual, English
1
47
For additional information on Blocking Screws and Extraction
Techniques, please reference the TRIGEN™ META-NAIL™ Tibial Nail
Surgical Technique, 7118-1610.
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova, TN 38016
USA
www.smith-nephew.com
Telephone: 1-901-396-2121
Information: 1-800-821-5700
Orders/Inquiries: 1-800-238-7538
™Trademark of Smith & Nephew. Certain marks Reg. US Pat. & TM Off.
© 2014 Smith & Nephew, Inc. All rights reserved.
01361 V1 71181612 REVB 01/14
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