The Distraction Osteogenesis Ring System. Nonarticular tibia frame.

The Distraction Osteogenesis Ring System. Nonarticular tibia frame.
The Distraction Osteogenesis Ring
System. Nonarticular tibia frame.
Technique Guide
Table of Contents
Introduction
Surgical Technique
Product Information
The Distraction Osteogenesis Ring System
2
MRI Information
4
AO Principles
5
Indications
6
Preparation
7
Ring Selection and Assembly
8
Frame Construction
9
Wire Insertion
11
Wire Fixation
14
Insertion of Wire at Opposite Bone End
15
Wire Tensioning
16
Insertion of Additional Wires
21
Tips and Alternative Technique
28
Implants and Fixation Material
29
Instruments
36
Set List
39
Image intensifier control
Synthes
The Distraction Osteogenesis Ring System
The Distraction Osteogenesis Ring System is a ring fixation
system. The ring fixation technique is based on the use of
transfixion wires and external fixation pins attached to rings
that encircle the affected limb. These rings are then attached
to each other with components such as threaded rods and
nuts to create a frame.
The modular nature of a ring fixation frame allows multiple
frame options. A ring fixation frame can be customized by the
surgeon to address the individual characteristics of each case.
Ring fixators are most commonly applied to the tibia, but also
can be applied to the femur, the humerus, the foot, the hand
and the forearm.
Ring fixators offer versatility and viable alternatives for
deformity corrections, in addition to fracture management.
Special components included in the system assist in angular
corrections, lengthening and compression. Ring fixation
systems allow generation of bone through distraction
and/or compression.
The main components of the system are transfixion wires
(smooth and reduction or “olive”), rings (half rings, full rings,
5/8 rings, femoral arches, and foot rings), threaded rods, nuts,
connection bolts and wire bolts. Other components available
include standoffs, locking hinges, angular distractors, linear
distractors, clamps, connecting plates, speed nuts, supports,
washers and Schanz screws. These components can be used
to create many frame configurations to address a wide variety
of applications.
2
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Additional features
– The Distraction Osteogenesis Ring
System is considered MR Conditional
– 8 mm threaded rods allow 3 rods
to be used in each ring block, saving
time and cost
– Compatible with the Synthes
medium external fixator, allowing
use of that system’s clamps, for more
freedom in Schanz screw placement
and versatility in frame design
– The 1.5 mm, 1.8 mm and 2.0 mm
smooth and reduction wires are
available with a new drill point tip
(half-point tip and spade-point wires
are also available)
– A wide variety of components are
available for compression, distraction,
angulation and translation of bone
segments
– Lightweight titanium alloy or carbon
fiber rings are available
Reduction wire
Reduction wire, half point tip
Linear distractor
Graphic cases and
removable modules
– Two graphic cases contain all
components and instruments
required for surgery: a ring case
and the implant and instrument
graphic case
– The implant and instrument graphic
case has adjustable bins and label
sheets so only the desired components need to be stored
– Removable modules included in the
implant and instrument graphic case
hold wires, wire bolts, connection
bolts and nuts
Synthes
3
MRI Information
Synthes Distraction Osteogenesis System devices are labeled
MR Conditional according to the terminology specified
in ASTM F2503-05, Standard Practice for Marking Medical
Devices and Other Items for Safety in the Magnetic
Resonance Environment.
Nonclinical testing demonstrated that, when used in
the specific configurations stated in Synthes labeling,
Synthes Distraction Osteogenesis Fixation devices are
MR Conditional. Representative Synthes Distraction
Osteogenesis Fixation devices used in a typical construct
include clamps, rods and various attachments. A patient
with a Synthes Distraction Osteogenesis External Fixation
frame may be scanned safely after placement of the frame
under the following conditions.
Static magnetic field of 1.5 Tesla when the fixation frame
is positioned:
– 7 cm or less from within the outside edge of the bore of
the MRI at Normal Operating Mode or;
– Completely outside of the MRI bore in First Level
Controlled Mode
Patients may be safely scanned in the MRI chamber at the
above conditions. Under such conditions, the maximal
expected temperature rise is less than 6ºC. Because higher
in vivo heating cannot be excluded, close patient monitoring
and communication with the patient during the scan is
required. Immediately abort the scan if the patient reports
burning sensation or pain. To minimize heating, the scan
time should be as short as possible, the SAR as low as
possible, and the device should be as far as possible from
the edge of the bore. Temperature rise values obtained were
based upon a scan time of 15 minutes.
The above field conditions should be compared with those
of the user’s MR system, to determine if the item can safely
be brought into the user’s MR environment. If placed in the
bore of the MR scanner during scanning, Synthes MR
Conditional external fixation devices may have the potential
to cause artifact in the diagnostic imaging.
All components of Synthes external fixation frames must be
identified as MR Conditional prior to being placed in or near
an MR environment.
Static magnetic field of 3.0 Tesla when the fixation frame
is positioned:
– 7 cm or less from within the outside edge of the bore of
the MRI at Normal Operating Mode or;
– Completely outside of the MRI bore in First Level
Controlled Mode
Artifact information
MR image quality may be compromised if the area of interest
is in the same area or relatively close to the position of the
Synthes Distraction Osteogenesis Fixation construct, and it
may be necessary to optimize MR imaging parameters, to
compensate for the presence of the fixation frame.
Highest spatial gradient magnetic field of 900 Gauss/cm
or less
Representative devices used to assemble a typical Synthes
Distraction Osteogenesis Fixation frame have been evaluated
in the MRI chamber and worst-case artifact information is
provided below. Overall, artifacts created by Synthes
Distraction Osteogenesis Fixation devices may present issues
if the MR imaging area of interest is in or near the area
where the fixation frame is located.
– For FFE sequence: Scan duration: 3 min, TR 100 ms,
TE 15 ms, flip angle 15º and SE sequence: Scan duration:
4 min, TR 500 ms, TE 20 ms, flip angle 70º radio echo
sequence, worst-case artifact will extend approximately
10 cm from the device.
Maximum MR system reported whole body averaged
specific absorption rate (SAR) of 2 W/kg for the Normal
Operating Mode and 4 W/kg for the First Level Controlled
Mode for 15 minutes of scanning
Use only whole body RF transmit coil, no other transmit
coils are allowed, local receive only coils are allowed
Note: In nonclinical testing, the Synthes external fixation
frame was tested in several different configurations. This
testing was conducted with the construct position 7 cm from
within the outside edge of the MRI bore.
– The results showed a maximum observed heating for the
distraction osteogenesis fixation frame of 6ºC for the
1.5 T and less then 1ºC for 3.0 T with a machine reported
whole body averaged SAR of 2 W/kg.
4
Synthes
Warning
– Do not place any radio frequency (RF) transmit coils
over the external fixation frame.
– Do not place the device across the growth plate in
pediatric patients.
The Distraction Osteogenesis Ring System Technique Guide
AO Principles
In 1958, the AO formulated four basic principles,
which have become the guidelines for internal fixation.1
Anatomic reduction
Fracture reduction and fixation to restore anatomic
relationships.
Stable fixation
Stability by fixation or splintage, as the personality
of the fracture and the injury require.
Preservation of blood supply
Preservation of the blood supply to soft tissue and bone
by careful handling.
Early, active mobilization
Early and safe mobilization of the part and patient.
1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger, Manual of
Internal Fixation, 3rd Edition. Berlin: Springer Verlag, 1991.
Synthes
5
Indications
The Synthes Distraction Osteogenesis
Ring System, MR Conditional is
intended to provide treatment for
long bone fractures (open and closed)
of adult and pediatric patients that
require external fixation.
6
Synthes
Specifically, the components can
be used for:
– Pseudoarthrosis or nonunions
of long bones
– Limb lengthening by epiphyseal
or metaphyseal distraction
– Correction of bony or soft tissue
deformities
– Correction of segmental bony
or soft tissue defects
The Distraction Osteogenesis Ring System Technique Guide
Preparation
Required set
01.311.000
Distraction Osteogenesis System Implant
and Instrument Set
Distraction Osteogenesis Ring System Threaded
Rod Spacing Chart
Use this chart to determine the optimal
spacing between threaded rods or
standoffs on rings
Required components and instruments
03.311.308– Titanium Half Rings
03.311.324 (80 mm–240 mm diameter)
511.791
530.100
Quick Coupling, for K-wires
Power Drive
Threaded rod spacing chart
The threaded rod spacing chart is an aid for determining
where threaded rods should be placed on the rings for
maximum stability, for the different ring sizes. Use the chart
during preoperative planning or when constructing a frame
to determine optimal spacing of the threaded rods.
Count
as holes
Ring Diameter
Place Threaded
Rod in Hole #
80 mm
7*
100 mm
9*
110 mm
10
120 mm
10*
130 mm
12
140 mm
12*
150 mm
13*
160 mm
14
180 mm
16
200 mm
17*
220 mm
14*
240 mm
15*
4
5
6
7
8
9 10 11 12 13 14
1
3
4
5
6
7
3
2
1
14
13
12
11
10
2
9
8
7 6
5 4
3 2
1
14
8
9
10
11
12
13
160 mm ring (shown)
*One interval will be longer for these diameters due to the fact that
the total number of holes is not divisible by 3 (or 4 for the 220 mm
and 240 mm rings)
© 2006 Synthes, Inc. or its affiliates. All rights reserved.
Synthes is a trademark of Synthes, Inc. or its affiliates.
Printed in U.S.A. 1/07 J7525-A
Patient positioning
Position the patient supine on a radiolucent table with the
affected limb elevated to provide access for the distraction
osteogenesis ring system frame, wires, and Schanz screws.
Note: This technique describes building the frame on the
patient. It is possible to build the frame using the same
construction techniques before placement on the patient,
in which case, the wires and Schanz screws are inserted after
frame construction and application. See page 28 for further
information on applying a prebuilt frame.
Synthes
7
Ring Selection and Assembly
1
Select half rings
Select two half rings (of the same size) that allow at least
2 cm of clearance between the limb and ring (take care to
measure at the thickest portion of the affected limb). Any
anticipated swelling of the limb must also be taken into
consideration.
2
Assemble half rings
Instrument
03.311.007
8 mm/11 mm Wrench
Place the two half rings around the limb. Connect the half
rings using two connection bolts. Take care to align a
threaded hole of one half ring with a nonthreaded hole of
the other. The number markings near the connection holes
on the half rings serve as guides and should be visible when
assembling the half rings. Thread the connection bolts
through the nonthreaded holes into the threaded holes from
the marked side of the rings. Tighten the bolts with
the wrench.
3
Assemble three more rings
Repeat Steps 1 and 2 three more times so that there is
a total of 4 assembled rings of the same diameter.
8
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Frame Construction
1
Connect two proximal rings
Instrument
03.311.007
8 mm/11 mm Wrench
Position the rings with the most proximal ring near the joint,
but no closer than 20 mm, tissue condition and anatomy
permitting. Position the next ring approximately 30 mm–
50 mm proximal to the affected area, tissue condition and
anatomy permitting. Align the connection bolts/joints of the
half rings. Use threaded rods and nuts and the 8 mm/11 mm
wrench to connect the rings. Typically, only three threaded
rods are necessary between each pair of rings (4 rods should
be used between pairs of 220 mm and 240 mm rings).
See the threaded rod spacing chart for the recommended
number of holes between threaded rods for each ring size.
Be sure that the rings remain parallel to each other after
they are connected.
2
Attach third ring to frame
Position the third assembled ring approximately 30 mm–
50 mm distal to the affected area, tissue condition and
anatomy permitting. Align the connection bolts/joints of
the half rings with those of the previously connected rings
and use threaded rods and nuts to connect this ring to them.
For maximum stability, position these threaded rods as
equally spaced as possible between the threaded rods from
the previous ring (see picture). Be sure that the rings remain
parallel to each other after they are connected.
Synthes
9
Frame Construction
3
Attach fourth ring to frame
Instrument
03.311.007
8 mm/11 mm Wrench
Position the fourth assembled ring near the distal joint, but
no closer than 20 mm, tissue condition and anatomy permitting. Align the connection bolts/joints of the half rings with
those of the previously connected rings and use threaded
rods and nuts to connect this ring to them. For maximum
stability, position these threaded rods as equally spaced as
possible between the threaded rods from the previous ring
(see picture). Be sure that the rings remain parallel to each
other after they are connected.
Technique tip: During the construction of a frame, it may
be helpful to insert a long threaded rod through all of the
rings to help keep them aligned.
Technique tip: When holes in the rings do not line up
properly (such as when different diameter rings are used),
spherical washer couples, locking hinges or connecting
plates may be used to connect the threaded rods to
adjacent rings.
10
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Wire Insertion
1
Wire selection
Select wires of appropriate size. The 1.8 mm and 2.0 mm
wires are commonly used for adult patients while 1.5 mm
wires are often used for small stature patients, or in the hand
or foot. Surgeon preference determines whether smooth
wires or reduction wires are used.
2
Wire insertion
Instruments
391.962
Bending/Cutting Pliers
511.791
Quick Coupling, for K-wires
530.100
Power Drive
Anterior
Posterior
An alcohol-soaked 4" x 4" sponge helps guide and cool the
wire. Do not start the drill until the wire tip makes contact
with the bone and stop drilling as soon as the tip protrudes
from the far cortex of the bone. Insert wires perpendicular to
the longitudinal axis of the affected limb, from the side with
the most vulnerable anatomy.
2. A. Fernández. “External Fixation.” AO Principles of Fracture Management.
T. Rüedi and W. Murphy, ed. Dübendorf, Switzerland; AO Publishing. 2000. 239.
Illustration modified and used with permission.
Tibial safe zones2
Synthes
11
Wire Insertion
Once the wire protrudes from the far cortex of the bone,
tap it through the tissue on the far side. The flat side of the
bending/cutting pliers may be used to tap the wire through
the tissue. Once the wire is through, cut off the tip to
prevent injury.
Insert a smooth wire near the joint that is furthest from the
injury site, perpendicular to the long axis of the bone and
parallel to the joint. Insert the wire from the side of the limb
with the most vulnerable anatomy. The wire should be no
closer than 20 mm to the joint surface. Place the limb in
longitudinal traction to aid in restoring length and reduction.
Alternative instruments
03.311.004
Ratchet Wrench, 11 mm
03.311.005
Split Tissue Protection Sleeve, 2.5 mm
399.41–
399.43
Hammers, 350–700 grams
399.50
Hammer, 100 grams
Alternative techniques
The 2.5 mm split tissue protection sleeve may be used
to hold the wire near the bone and aid in protecting the
soft tissue.
Use the flat side of the ratchet wrench or a hammer to
tap the wire through the soft tissue.
12
Synthes
The Distraction Osteogenesis Ring System Technique Guide
3
Position frame on wire
Move the frame into the proper position along the wire.
Position the half ring joints over anatomy features that
would prevent wire insertion (there are fewer holes near the
half ring joint). In the tibia, this places the connection bolts
over the tibial crest or just lateral to it. Confirm that the
frame sits with the rings perpendicular to the long axis of
the bone. If the frame is not properly aligned with the bone,
reposition the wire.
Synthes
13
Wire Fixation
1
Attach wire to ring
Instrument
03.311.007
8 mm/11 mm Wrench
Use wire bolts to connect the wire to the ring. Choose either
offset wire bolts or slotted wire bolts, depending on the
position of the wire in relation to the holes in the ring. The
wire should remain in a neutral position. Thread the bolts
from below or above the ring, depending on where the wire
sits. The wire should be between the bolt head and the ring.
Use spacing washers between the bolt head and the ring or
use wire posts if the wire does not contact the ring without
bending. Do not bend wires to attach them to the ring
(unless more advanced reduction techniques are being used).
Fasten the bolts with nuts (standard or square). Tighten the
nuts onto the bolts by hand; leave them loose enough to
allow the rings to be easily repositioned on the wire.
14
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Insertion of Wire at Opposite Bone End
1
Repeat wire insertion at opposite end of bone
Instruments
03.311.004
Ratchet Wrench, 11 mm
03.311.007
8 mm/11 mm Wrench
Insert a wire in the opposite end of the affected bone as
was done at the first ring. Use wire bolts and nuts to attach
this wire to the ring.
Synthes
15
Wire Tensioning
1
Tighten one wire bolt and nut opposite from
tensioning side
Instrument
03.311.007
8 mm/11 mm Wrench
Use two wrenches to tighten the nut and wire bolt opposite
from where tension will be applied. When reduction wires
are used, tighten the side with the stopper. Take care to keep
the wire bolt head aligned, to prevent bending the wire.
Correct
16
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Incorrect
2
Position tensioner on wire
Instruments
03.311.001
a
Tensioner
03.311.220– Standoffs
03.311.250
b
From the tensioning side of the ring, pass the wire into the
cannulation of the tensioner. The tensioner should be fully
open (the black handle turned counterclockwise until it
stops) and the teeth on the front of the device seated
securely against the ring, to ensure proper tensioning of
the wire. Center the wire bolt and nut between the teeth
of the tensioner.
Tighten offset bolt (a) opposite the tensioner before
tensioning.
Leave offset bolt (b) loose when tensioning. Tighten after
the wire is tensioned.
If other features prevent the teeth from sitting on the ring,
place a standoff on the wire between the tensioner and the
ring. The threaded tip allows the standoff to be threaded
onto the tensioner.
Synthes
17
Wire Tensioning
3
Apply tension to wire
Instruments
03.311.001
Tensioner
03.311.004
Ratchet Wrench, 11 mm
Turn the tensioner handle clockwise until the desired tension
is attained. Typical wire tensions used are:
–
–
–
–
When attached to a ring: 130 kg
When attached to a ring on a small stature patient: 100 kg
When positioned off of a ring: 50 kg–75 kg
When positioned in the hand or foot: 50 kg–75 kg
Optional technique
A ratchet wrench can be used on the external hex nut at the
back of the tensioner to make turning the handle quicker.
18
Synthes
The Distraction Osteogenesis Ring System Technique Guide
4
Tighten wire bolt and nut
Instruments
03.311.002
Slotted Socket Wrench, 11 mm
03.311.004
Ratchet Wrench, 11 mm
When the wire is fully tensioned, tighten the wire bolt near
the tensioner. A slotted socket wrench can be used to hold
the wire bolt head straight while a ratchet wrench is used to
tighten the nut onto the bolt (or two ratchet wrenches may
be used). Repeat this process for the remaining wire(s). After
tensioning all the wires on a ring, retension them in the
same sequence to maintain appropriate tension and obtain
the best frame stability, with minimal deformation of the
rings. After all wires have been tensioned, all nuts and bolts
should be checked for tightness.
Alternative techniques
Use two tensioners from opposite sides to simultaneously
tension two wires to maintain appropriate tension and
obtain the best frame stability.
Reduction wires are not always tensioned, as when they are
used to reduce a fracture by transporting a segment over
time. In this case, the end of the wire with the stopper is not
secured to the ring. The opposite end may be held in a slotted threaded rod with two nuts and inserted through an eye
bolt. The threaded rod can be pulled through the eye bolt
using another nut, thereby moving the wire and the bone
fragment that is held by the stopper.
Synthes
19
Wire Tensioning
5
Cut ends of wire
Instrument
391.962
Bending/Cutting Pliers
After tensioning, cut the ends of the wire. Leave at least
60 mm (approximately 3 finger widths) of wire past the wire
bolt so that there is sufficient wire to grab if the wire needs
tightening. Curl the end of the wire using the bending/
cutting pliers.
6
Tension wire at distal ring
Repeat the tensioning process on the wire that is attached
to the distal ring.
20
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Insertion of Additional Wires at First Ring
1
Insert two additional wires at first ring
Place two more wires in the tibia at the first ring, perpendicular to the long axis of the bone. One wire should be above
the ring and one below with the third wire inserted diagonally starting below the ring and ending above it on the
opposite side. The third wire may also be inserted a few
millimeters above or below the rings. These techniques help
prevent the wires from hitting each other inside the bone or
tissue. A wire may be weakened if it is contacted by the tip
of another wire as it is inserted. Insert the wires so that they
cross in the bone at as large an angle as the anatomy permits, to prevent the bone from moving along the wires and
provide maximum stability. Counter-opposing reduction
(olive) wires can help stabilize this bone segment.
2
Attach wires to ring
Instrument
03.311.007
8 mm/11 mm Wrench
Use wire bolts and nuts to attach the wires to the ring,
taking care not to bend the wires.
3
Tension wires
Tension, tighten and cut both wires as described on
pages 16–20.
Synthes
21
Insertion of Additional Wires at Opposite Bone End
1
Repeat wire insertion at opposite end of bone
Insert two more wires in the opposite end of the affected
bone as was done at the first ring. Refer to Step 1 on
page 21.
2
Attach wires to ring
Use wire bolts and nuts to attach the wires to the ring taking
care not to bend the wires.
3
Tension wires
Tension, tighten and cut both wires as described on
pages 16–20.
22
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Insertion of Remaining Wires
1
Insert wire in proximal segment near affected area
Instrument
03.311.007
8 mm/11 mm Wrench
Insert a wire at the ring that is 30 mm–50 mm proximal to
the affected area. Connect the wire to the ring as described
on page 14.
Synthes
23
Insertion of Remaining Wires
2
Insert wire in distal segment near affected area
Insert a wire at the ring that is 30 mm–50 mm distal to the
affected area. Connect the wire to the ring as described on
page 14.
Alternative technique
Reduction wires may be used instead of smooth wires to aid
in reduction. If reduction wires are used, they are placed with
the stoppers on opposite sides of the bone to help hold the
segments together.
24
Synthes
The Distraction Osteogenesis Ring System Technique Guide
3
Insert second wire in proximal segment near
affected area
Insert a second wire at the ring that is just proximal to the
fracture. Insert this wire on the opposite face of the ring
from the first wire, to prevent the wires from contacting
and damaging each other. Insert this wire so that the
angle between it and the previously inserted wire is as
large as possible.
Synthes
25
Insertion of Remaining Wires
4
Insert second wire in distal segment near affected area
Insert a second wire at the ring that is just distal to the
fracture. Insert this wire on the opposite face of the ring
from the first wire, to prevent the wires from contacting
and damaging each other. Insert this wire so that the
angle between it and the previously inserted wire is as
large as possible.
26
Synthes
The Distraction Osteogenesis Ring System Technique Guide
5
Attach and tension remaining wires
Instruments
03.311.001
Tensioner
03.311.002
Slotted Socket Wrench, 11 mm
03.311.004
Ratchet Wrench, 11 mm
03.311.007
8 mm/11 mm Wrench
391.962
Bending/Cutting Pliers
Attach the wires to the middle two rings with wire bolts
as before and tension, tighten and cut them as described on
pages 16–20.
Alternative technique
If reduction wires are used to help reduce a fragment,
they are usually not tightened on the opposite side of the
tensioner until the fragment is pulled into the desired
position by the tensioner. Then the opposite wire bolt
can be tightened and the wire tensioned.
6
Check wires and connections
Check all of the wires for tension and all connections
for tightness.
Synthes
27
Tips and Alternative Technique
Tips
Alternative technique
Wire-site and pin-site care
Wire sites and pin sites should be cared for meticulously to
avoid wire-tract and pin-tract infection. Wires and Schanz
screws may be surrounded with antiseptic coated foam
sponges in an effort to avoid infection. A wire- and pin-site
care program should be reviewed with the patient.
Prebuilding a frame
Prebuild the distraction osteogenesis ring system frame
and apply it in the operating room. Preoperative planning is
required for construction of the appropriate frame. X-rays of
1:1 scale can be helpful when constructing such frames. The
frame may also be constructed in the operating room, off
the patient. Once the frame is constructed, the connection
bolts may be loosened on the rings to allow the frame to
open up and be placed around the limb. Insert a wire in the
tibia near the joint most distal to the affected area, no closer
than
20 mm to the joint. Attach the frame to the wire using wire
bolts and nuts. Insert a wire near the other joint, using the
preconstructed frame as a reference. This wire should be
no closer than 20 mm to that joint. Attach this wire to the
frame with wire bolts and nuts. Tension both wires. Place
additional wires at the proximal ring and distal ring. Insert
wires at the middle two rings as described on pages 23–26,
using the rings as references when placing the wires. Tension
and tighten all the wires.
Use of Schanz screws
Schanz screws may be used in the place of wires, or with
wires (usually one Schanz screw in the place of one wire on a
ring). Hydroxyapatite-coated Schanz screws are also available
and may also be used with the system. The distraction
osteogenesis ring system contains a variety of clamps and
bolts that can be used to attach Schanz screws to the frame.
The medium open adjustable clamp (390.035), the medium
combination clamp (390.031) and the 8.0 mm/11.0 mm
combination clamp (390.037) can also be used to fix Schanz
screws to threaded rods. Various drill sleeves are available
that can be inserted in the clamps and bolts to aid in Schanz
screw insertion.
Limb positioning
Surgeons often use suction tubing and clamps to suspend
the limb in the rings when applying the frame. Bumps or
stands may also be used.
28
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Implants and Fixation Material, MR Conditional
219.98
Washer, 7.0 mm
294.785
175 mm
294.786
200 mm
5.0 mm Self-Drilling Schanz Screws
03.311.010 Schanz Screw Bolt
03.311.015* Schanz Screw Bolt, 2 piece
03.311.011
Pivot Schanz Screw Clamp
03.311.012
Locking Hinge
Smooth Wires
/ /
03.311.031* 1.5 mm diameter, 400 mm long
03.311.032
1.8 mm diameter, 400 mm long
03.311.033* 2.0 mm diameter, 400 mm long
Reduction Wires
/ /
03.311.041* 1.5 mm diameter, 400 mm long
03.311.042
1.8 mm diameter, 400 mm long
03.311.043* 2.0 mm diameter, 400 mm long
*Also available
Synthes
29
Implants and Fixation Material, MR Conditional
03.311.050
03.311.051
03.311.054
Wire Bolts
Slotted
Offset
Offset, short
03.311.055
Connection Bolt
03.311.060
Square Nut
03.311.061
Nut
03.311.070
03.311.071
03.311.171*
03.311.172*
03.311.173*
03.311.174*
03.311.175*
Wire Posts
Short
Tall
1 hole
2 hole
3 hole
4 hole
5 hole
Spacing Washers
03.311.081
1 mm
03.311.082
2 mm
03.311.084
4 mm
03.311.090
Spherical Washer Couple
*Also available
30
Synthes
The Distraction Osteogenesis Ring System Technique Guide
03.311.091
Oblique Support
03.311.092
Eye Bolt
03.311.106
60 mm long, slotted
03.311.108
80 mm long, slotted
Threaded Rods
03.311.110
100 mm long, slotted
03.311.112
120 mm long
03.311.115
150 mm long
03.311.120
200 mm long
03.311.125
250 mm long
03.311.130
300 mm long
03.311.135
350 mm long
03.311.140* 400 mm long
03.311.022
03.311.023
03.311.024
03.311.025
Connecting Plates, 90º offset*
2 hole
3 hole
4 hole
5 hole
Connecting Plates
03.311.201* 1 hole
03.311.202* 2 holes
03.311.203
3 holes
03.311.204
4 holes
03.311.205* 5 holes
03.311.212
03.311.213
03.311.214
03.311.215
Connecting Plates, threaded*
2 hole
3 hole
4 hole
5 hole
*Also available
Synthes
31
Implants and Fixation Material, MR Conditional
Standoffs
03.311.220* 20 mm
03.311.230
30 mm
03.311.240
40 mm
03.311.250* 50 mm
03.311.450
Angular Distractor
03.311.451
Angular Distractor Pivot
394.993
Protective Caps, for 5.0 mm Fixation Pins
Also Available
03.311.013
Schanz Screw Bolt, post mount
03.311.020
Universal Hinge
Smooth Wires
03.311.036
03.311.037
1.8 mm diameter, half point tip
03.311.038
2.0 mm diameter, half point tip
Reduction Wires
03.311.046
1.5 mm diameter, half point tip
03.311.047
1.8 mm diameter, half point tip
03.311.048
2.0 mm diameter, half point tip
*Also available
32
Synthes
/ /
1.5 mm diameter, half point tip
The Distraction Osteogenesis Ring System Technique Guide
/ /
/ /
Also Available
03.311.056
Connection Bolt, long
03.311.058
Schanz Screw Bolt, Cannulated Ring Mount
03.311.059
Schanz Screw Bolt, Cannulated Post Mount
03.311.062
Speed Nut
Titanium Half Rings
03.311.308
80 mm diameter
03.311.310
100 mm diameter
03.311.311
110 mm diameter
03.311.312
120 mm diameter
03.311.313
130 mm diameter
03.311.314
140 mm diameter
03.311.315
150 mm diameter
03.311.316
160 mm diameter
03.311.318
180 mm diameter
03.311.320
200 mm diameter
03.311.322
220 mm diameter
03.311.324
240 mm diameter
Titanium Full Rings
03.311.344
140 mm diameter
03.311.346
160 mm diameter
03.311.348
180 mm diameter
03.311.350
200 mm diameter
Synthes
33
Also Available
Titanium 5/8 Rings
03.311.373
130 mm diameter
03.311.375
150 mm diameter
03.311.376
160 mm diameter
03.311.378
180 mm diameter
03.311.380
200 mm diameter
Titanium Femoral Arch Plate
03.311.391
180 mm diameter, 90°
03.311.392
180 mm diameter, 120°
03.311.396
240 mm diameter, 90°
03.311.397
240 mm diameter, 120°
Titanium Foot Rings
03.311.960
100 mm, short
03.311.964
140 mm, short
03.311.966
160 mm. short
03.311.968
180 mm, short
03.311.970
200 mm, short
03.311.980
100 mm, long
03.311.984
140 mm, long
03.311.986
160 mm, long
03.311.988
180 mm, long
03.311.990
200 mm, long
Linear Distractors
03.311.406
60 mm long, 25 mm travel
03.311.412
120 mm long, 85 mm travel
03.311.418
180 mm long, 145 mm travel
03.311.425
250 mm long, 215 mm travel
34
Synthes
The Distraction Osteogenesis Ring System Technique Guide
Carbon Fiber Half Rings
03.311.810
100 mm diameter
03.311.812
120 mm diameter
03.311.814
140 mm diameter
03.311.816
160 mm diameter
03.311.818
180 mm diameter
03.311.820
200 mm diameter
03.311.874
140 mm diameter
03.311.876
160 mm diameter
03.311.878
180 mm diameter
03.311.880
200 mm diameter
Carbon Fiber 5/8 Rings
Carbon Fiber Femoral Arch Plates
03.311.891
180 mm diameter, 90°
03.311.892
180 mm diameter, 120°
03.311.896
240 mm diameter, 90°
03.311.897
240 mm diameter, 120°
Carbon Fiber Foot Rings
03.311.910
100 mm diameter, short
03.311.914
140 mm diameter, short
03.311.916
160 mm diameter, short
03.311.918
180 mm diameter, short
03.311.940
100 mm diameter, long
03.311.944
140 mm diameter, long
03.311.946
160 mm diameter, long
03.311.948
180 mm diameter, long
Synthes
35
DO Instruments, MR Unsafe*
03.311.001
Tensioner
03.311.002
Slotted Socket Wrench, 11 mm
03.311.004
Ratchet Wrench, 11 mm
03.311.005
Split Tissue Protection Sleeve, 2.5 mm
03.311.006
Split Tissue Protection Sleeve, 5 mm
03.311.007
8 mm/11 mm Wrench
03.311.008
Backup Tensioner
* MR Unsafe: An item that is known to pose hazards in all MR environments,
per ASTM F2503-08 definition.
36
Synthes
The Distraction Osteogenesis Ring System Technique Guide
03.311.003* Patient Wrench, 8 mm/11 mm
General Instruments
310.37
3.5 mm Drill Bit, quick coupling, 195 mm
391.962
Bending/Cutting Pliers
393.103
Drive Adaptor with quick coupling,
for 5.0 mm Schanz screws
393.105
Small Universal Chuck with T-Handle
394.182
3.5 mm Trocar, 118 mm (long)
395.911
Drill Sleeve Handle
/ /
*Also available
Synthes
37
General Instruments
395.913
5.0 mm/3.5 mm Drill Sleeve, 107 mm (long)
395.923
6.0 mm/5.0 mm Threaded Drill Sleeve,
98 mm (long)
Also Available
Drive Adaptors with quick coupling
393.101
For 4.0 mm Schanz screws
393.102
For 4.5 mm Schanz screws
393.104
For 6.0 mm Schanz screws
Hammers
399.41
350 grams
399.42
500 grams
399.43
700 grams
399.50
100 grams
38
Synthes
The Distraction Osteogenesis Ring System Technique Guide
The Distraction Osteogenesis Ring System Implant and Instrument Set
(01.311.000)
Graphic Case
690.454
Distraction Osteogenesis System Implants
and Instruments Graphic Case
690.822
Label Sheet, for Distraction Osteogenesis
Components
690.829
Label Sheet, for Distraction Osteogenesis
Threaded Rods
Instruments
03.311.001
03.311.002
03.311.004
03.311.005
03.311.006
03.311.007
03.311.008
310.37
391.962
393.103
393.105
394.182
395.911
395.913
395.923
Tensioner
Slotted Socket Wrench, 11 mm, 2 ea.
Ratchet Wrench, 11 mm, 2 ea.
Split Tissue Protection Sleeve, 2.5 mm
Split Tissue Protection Sleeve, 5 mm
8 mm/11 mm Wrench, 2 ea.
Backup Tensioner
3.5 mm Drill Bit, quick coupling, 195 mm
Bending/Cutting Pliers
Drive Adaptor with quick coupling, for
5.0 mm Schanz Screws, 2 ea.
Small Universal Chuck with T-handle
3.5 mm Trocar, 118 mm (long)
Drill Sleeve Handle
5.0 mm/3.5 mm Drill Sleeve, 107 mm (long)
6.0 mm/5.0 mm Threaded Drill Sleeve,
98 mm (long)
Implants and Fixation Material
219.98
Washer, 7.0 mm, 12 ea.
294.785
5.0 mm Self-Drilling, 175 mm, 8 ea.
294.786
5.0 mm Self-Drilling, 200 mm, 8 ea.
03.311.010
Schanz Screw Bolt, 3 ea.
03.311.011
Pivot Schanz Screw Clamp, 2 ea.
03.311.012
Locking Hinge, 4 ea.
03.311.032
Smooth Wire, 1.8 mm diameter, 400 mm
long, 20 ea.
03.311.042
Reduction Wire, 1.8 mm diameter, 400 mm
long, 20 ea.
Note: For additional information, please refer to package insert.
For detailed cleaning and sterilization instructions, please refer to
http://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htm
or to the below listed inserts, which will be included in the shipping container:
– Processing Synthes Reusable Medical Devices — Instruments, Instrument Trays
and Graphic Cases — DJ1305
– Processing Non-sterile Synthes Implants — DJ1304
Synthes
39
The Distraction Osteogenesis Ring System Implant and Instrument Set (01.311.000)
Implants and Fixation Material
03.311.050
Wire Bolt, slotted, 20 ea.
03.311.051
Wire Bolt, offset, 60 ea.
03.311.055
Connection Bolt, 40 ea.
03.311.060
Square Nut, 6 ea.
03.311.061.10 Nut, 12 pkgs. of 10
03.311.070
Wire Post, short, 4 ea.
03.311.071
Wire Post, tall, 2 ea.
03.311.081
Spacing Washer, 1 mm, 40 ea.
03.311.082
Spacing Washer, 2 mm, 20 ea.
03.311.084
Spacing Washer, 4 mm, 10 ea.
03.311.090
Spherical Washer Couple, 8 ea.
03.311.091
Oblique Support, 4 ea.
03.311.092
Eye Bolt, 2 ea.
03.311.106
03.311.108
03.311.110
03.311.112
03.311.115
03.311.120
03.311.125
03.311.130
03.311.135
03.311.203
03.311.204
03.311.230
03.311.240
03.311.450
03.311.451
394.993
40
Synthes
Threaded Rods
60 mm length, slotted, 6 ea.
80 mm length, slotted, 6 ea.
100 mm length, slotted, 6 ea.
120 mm length, 6 ea.
150 mm length, 6 ea.
200 mm length, 6 ea.
250 mm length, 6 ea.
300 mm length, 3 ea
350 mm length, 3 ea.
Connecting Plate, 3 holes, 3 ea.
Connecting Plate, 4 holes, 3 ea.
Standoff, 30 mm, 6 ea.
Standoff, 40 mm, 6 ea.
Angular Distractor, 2 ea.
Angular Distractor Pivot, 2 ea.
Protective Caps, for 5.0 mm Fixation Pins,
1 pkg. of 10
The Distraction Osteogenesis Ring System Technique Guide
Also Available
Instruments
03.311.003
Patient Wrench, 8 mm/11 mm
393.101
393.102
393.104
Drive Adaptors with quick coupling
For 4.0 mm Schanz screws
For 4.5 mm Schanz screws
For 6.0 mm Schanz screws
399.41
399.42
399.43
399.50
Hammers
350 grams
500 grams
700 grams
100 grams
511.791
530.100
Quick Coupling, for K-wires
Power Drive
Implants and Fixation Material
03.311.013
Schanz Screw Bolt, post mount
03.311.015
Schanz Screw Bolt, 2 piece
03.311.020
Universal Hinge
03.311.022
03.311.023
03.311.024
03.311.025
Connecting Plates, 90˚ offset
2 hole
3 hole
4 hole
5 hole
03.311.031
03.311.033
03.311.036
03.311.037
03.311.038
Smooth Wires
1.5 mm diameter, 400 mm length
2.0 mm diameter, 400 mm length
1.5 mm diameter, half point tip
1.8 mm diameter, half point tip
2.0 mm diameter, half point tip
03.311.041
03.311.043
03.311.046
03.311.047
03.311.048
Reduction Wires
1.5 mm diameter, 400 mm length
2.0 mm diameter, 400 mm length
1.5 mm diameter, half point tip
1.8 mm diameter, half point tip
2.0 mm diameter, half point tip
03.311.054
03.311.056
03.311.058
03.311.059
Wire Bolt, offset, short
Connection Bolt, long
Schanz Screw Bolt, Cannulated Ring Mount
Schanz Screw Bolt, Cannulated Post Mount
03.311.062
03.311.140
Speed Nut
Threaded Rod, 400 mm long
03.311.171
03.311.172
03.311.173
03.311.174
03.311.175
Wire Posts
1 hole
2 hole
3 hole
4 hole
5 hole
03.311.200
03.311.201
03.311.202
03.311.205
Connecting Plates, for Carbon Fiber Rings
1 hole
1 hole
2 holes
5 holes
03.311.212
03.311.213
03.311.214
03.311.215
Connecting Plates, threaded
2 hole
3 hole
4 hole
5 hole
03.311.220
03.311.250
Standoff, 20 mm
Standoff, 50 mm
03.311.308
03.311.310
03.311.311
03.311.312
03.311.313
03.311.314
03.311.315
03.311.316
03.311.318
03.311.320
03.311.322
03.311.324
Titanium Half Rings
80 mm diameter
100 mm diameter
110 mm diameter
120 mm diameter
130 mm diameter
140 mm diameter
150 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
220 mm diameter
240 mm diameter
03.311.344
03.311.346
03.311.348
03.311.350
Titanium Full Rings
140 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
Synthes
41
Also Available
03.311.373
03.311.375
03.311.376
03.311.378
03.311.380
Titanium 5/8 Rings
130 mm diameter
150 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
03.311.391
03.311.392
03.311.396
03.311.397
Titanium Femoral Arch Plates
180 mm diameter, 90°
180 mm diameter, 120°
240 mm diameter, 90°
240 mm diameter, 120°
03.311.406
03.311.412
03.311.418
03.311.425
Linear Distractors
60 mm long, 25 mm travel
120 mm long, 85 mm travel
180 mm long, 145 mm travel
250 mm long, 215 mm travel
03.311.810
03.311.812
03.311.814
03.311.816
03.311.818
03.311.820
Carbon Fiber Half Rings
100 mm diameter
120 mm diameter
140 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
03.311.844
03.311.846
03.311.848
03.311.850
Carbon Fiber Full Rings
140 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
03.311.874
03.311.876
03.311.878
03.311.880
Carbon Fiber 5/8 Rings
140 mm diameter
160 mm diameter
180 mm diameter
200 mm diameter
03.311.891
03.311.892
03.311.896
03.311.897
Carbon Fiber Femoral Arch Plates
180 mm diameter, 90°
180 mm diameter, 120°
240 mm diameter, 90°
240 mm diameter, 120°
42
Synthes
03.311.910
03.311.914
03.311.916
03.311.918
03.311.940
03.311.944
03.311.946
03.311.948
Carbon Fiber Foot Rings
100 mm diameter, short
140 mm diameter, short
160 mm diameter, short
180 mm diameter, short
100 mm diameter, long
140 mm diameter, long
160 mm diameter, long
180 mm diameter, long
03.311.960
03.311.964
03.311.966
03.311.968
03.311.970
03.311.980
03.311.984
03.311.986
03.311.988
03.311.990
Titanium Foot Rings
100 mm, short
140 mm, short
160 mm, short
180 mm, short
200 mm, short
100 mm, long
140 mm, long
160 mm, long
180 mm, long
200 mm, long
390.031
390.035
390.037
Clamps
Medium Combination Clamp
Medium Open Adjustable Clamp
8.0 mm/11.0 mm Combination Clamp
The Distraction Osteogenesis Ring System Technique Guide
Graphic Case Replacement Parts
304.454
Offset Bolt Rack
304.455
Slotted Bolt Rack
304.456
Connection Bolt Rack
304.457
Wire Box
304.458
Stopper for Bolt Racks
304.459
Long Connection Bolt Rack
690.455
Ring Rack for Distraction Osteogenesis
System Ring Case
690.458
Ring Rack for Graphic Case, for Distraction
Osteogenesis Carbon Fiber Rings
690.821
Label Sheet, for Distraction Osteogenesis
Rings
690.822
Label Sheet, for Distraction Osteogenesis
Components
690.829
Label Sheet, for Distraction Osteogenesis
Threaded Rods
Graphic Cases for Distraction Osteogenesis Rings
690.452
Full Case
690.453
Half Case
690.456
Stacked Case
690.457
For Carbon Fiber Rings
Synthes
43
Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
© 2007 Synthes, Inc. or its affiliates. All rights reserved.
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185
Synthes is a trademark of Synthes, Inc. or its affiliates.
www.synthes.com
Printed in U.S.A. 12/10 J7247-C
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