Large and Medium External Fixators
Large and Medium External Fixators
This description alone does not provide sufficient background for direct use
of DePuy Synthes products. Instruction by a surgeon experienced in handling
these products is highly recommended.
Please refer to the IFU for product information including but not limited to
indications, contraindications, warnings, precautions and adverse effects.
AO Principles 5
MRI Information 7
Instruments 42
User-oriented handling
• Clamps with a clip-on self-holding m
echanism
• Color-coded for identification
Medium rod 8 mm
Small rod 4 mm
Mini rod 3 mm
External Mini-Fixator
Mission
The AO’s mission is promoting excellence
in patient care and outcomes in trauma
and musculoskeletal disorders.
AO Principles 1,2
1 2 3 4
Fracture reduction and Fracture fixation provid- Preservation of the blood Early and safe mobiliza-
fixation to restore ing absolute or relative supply to soft-tissues and tion and rehabilitation
anatomical relationships. stability, as required by bone by gentle reduction of the injured part and
the “personality” of the techniques and careful the patient as a whole.
fracture, the patient, handling.
and the injury.
Indications
The Large External Fixator (rod diameter: 11 mm) is
particularly suitable for treating the lower extremities.
The Medium External Fixator (rod diameter: 8 mm) is
particularly appropriate for the extremities of adults,
and the upper and lower extremities of children and
small adults.
Contraindications
No specific contraindications.
Large External Fixator The above field conditions should be compared with
Large External Fixator devices used in a typical construct those of the user’s MR system in order to determine
include clamps, rods and various attachments. A patient if the item can safely be brought into the user’s MR
with a DePuy Synthes Large External Fixator frame may environment.
be scanned safely after placement of the frame under
the following conditions: If placed in the bore of the MR scanner during scan-
ning, DePuy Synthes Large External Fixator devices
• Static magnetic field of 1.5 Tesla or 3.0 Tesla when the may have the potential to cause artifact in the diag-
fixator frame is positioned outside the MRI Bore at nostic imaging.
Normal Operator or in First Level Control Mode
• Highest spatial gradient magnetic field of 720 Gauss/cm Warnings:
or less • Only use frame components stated in the surgical
• Maximum MR system reported whole body averaged technique of the Large External Fixator System
specific absorption rate (SAR) of 2 W/kg for the Normal • Potential complications of putting a part in the MR
Operating Mode and 4 W/kg for the First Level Con- field are:
trolled Mode for 15 minutes of scanning –– Torsional forces can cause the device to twist
• Use only whole body RF transmit coil, no other trans- in MR field
mit coils are allowed, local receive only coils are al- –– Displacement forces can pull the device into
lowed the MR field
• Specialty coils, such as knee or head coils, should not –– Induced currents can cause peripheral nerve
be used as they have not been evaluated for RF heat- stimulation
ing and may result in higher localized heating –– Radio Frequency (RF) induced currents can
cause heating of the device that is implanted
Note: In nonclinical testing, the Large External Fix- in the patient
ator frame was tested in several different configura- • Do not place any radio frequency (RF) transmit
tions. This testing was conducted with the construct coils over the Large External Fixator frame
position 7 cm from within the outside edge of the
MRI bore. Artifact Information
The results showed a maximum observed heating MR image quality may be compromised if the area of in-
for a pelvic frame of less than 1 °C for 1.5 T and terest is in the same area or relatively close to the position
3.0 T with a machine reported whole body averaged of the DePuy Synthes Large External Fixator frame. It may
SAR of 2 W/kg. be necessary to optimize MR imaging parameters in order
to compensate for the presence of the fixator frame.
Precautions: Patients may be safely scanned in the
MRI chamber under the above conditions. Under Representative devices used to assemble a typical Large
such conditions, the maximum expected tempera- External Fixator frame have been evaluated in the MRI
ture rise is less than 6 °C. Because higher in vivo chamber and worst-case artifact information is provided
heating cannot be excluded, close patient monitor- below. Overall, artifacts created by DePuy Synthes Large
ing and communication with the patient during the External Fixator System devices may present issues if the
scan are required. Immediately abort the scan if the MR imaging area of interest is in or near the area where
patient reports burning sensation or pain. To mini- the fixator frame is located.
mize heating, the scan time should be as short as • For FFE sequence: scan duration 3 minutes, TR 100 ms,
possible, the SAR as low as possible and the device TE 15 ms, flip angle 15° and SE sequence: scan dura-
should be as far as possible from the edge of the tion 4 minutes, TR 500 ms, TE 20 ms, flip angle 70°
bore. Temperature rise values obtained were based radio echo sequence, worst-case artifact will extend
upon a scan time of 15 minutes. approximately 10 cm from the device.
Medium External Fixator The above field conditions should be compared with
Medium External Fixator devices used in a typical con- those of the user’s MR system in order to determine
struct include clamps, rods and various attachments. if the item can safely be brought into the user’s MR
A patient with a DePuy Synthes Medium External Fixator environment.
frame may be scanned safely after placement of the
frame under the following conditions: If placed in the bore of the MR scanner during scan-
ning, DePuy Synthes Medium External Fixator de-
• Static magnetic field of 1.5 Tesla or 3.0 Tesla when the vices may have the potential to cause artifact in the
fixator frame is positioned: diagnostic imaging.
–– 7 cm or less from within the outside edge of the
bore of the MRI at Normal Operating Mode or Warnings:
–– Completely outside of the MRI Bore in First Level • Only use frame components stated in the surgical
Control Mode technique of the Medium External Fixator System
• Highest spatial gradient magnetic field of 900 Gauss/cm • Potential complications of putting a part in the MR
or less field are:
• Maximum MR system reported whole body averaged –– Torsional forces can cause the device to twist
specific absorption rate (SAR) of 2 W/kg for the Normal in MR field
Operating Mode and 4 W/kg for the First Level Con- –– Displacement forces can pull the device into
trolled Mode for 15 minutes of scanning the MR field
• Use only whole body RF transmit coil, no other trans- –– Induced currents can cause peripheral nerve
mit coils are allowed, local receive only coils are al- stimulation
lowed –– Radio Frequency (RF) induced currents can
cause heating of the device that is implanted
Note: In nonclinical testing, the Medium External in the patient
Fixator frame was tested in several different config- • Do not place any radio frequency (RF) transmit
urations. This testing was conducted with the con- coils over the Medium External Fixator frame
struct position 7 cm from within the outside edge of
the MRI bore. Artifact Information
The results showed a maximum observed heating MR image quality may be compromised if the area of in-
for a wrist fixator frame of 6 °C for 1.5 T and less terest is in the same area or relatively close to the position
than 1 °C for 3.0 T with a machine reported whole of the DePuy Synthes Medium External Fixator frame. It
body averaged SAR of 2 W/kg. may be necessary to optimize MR imaging parameters in
order to compensate for the presence of the fixator frame.
Precautions: Patients may be safely scanned in the
MRI chamber under the above conditions. Under Representative devices used to assemble a typical Medium
such conditions, the maximum expected tempera- External Fixator frame have been evaluated in the MRI
ture rise is less than 6 °C. Because higher in vivo chamber and worst-case artifact information is provided
heating cannot be excluded, close patient monitor- below. Overall, artifacts created by DePuy Synthes
ing and communication with the patient during the Medium External Fixator System devices may present
scan are required. Immediately abort the scan if the issues if the MR imaging area of interest is in or near the
patient reports burning sensation or pain. To mini- area where the fixator frame is located.
mize heating, the scan time should be as short as • For FFE sequence: scan duration 3 minutes, TR 100 ms,
possible, the SAR as low as possible and the device TE 15 ms, flip angle 15° and SE sequence: scan dura-
should be as far as possible from the edge of the tion 4 minutes, TR 500 ms, TE 20 ms, flip angle 70°
bore. Temperature rise values obtained were based radio echo sequence, worst-case artifact will extend
upon a scan time of 15 minutes. approximately 10 cm from the device.
Precautions:
• When dealing with the humerus, primary consid-
eration should be given to the radial and axillary
nerves.
• Proximally, it is recommendable to introduce the
Schanz screws from a ventrolateral direction, cau-
dal to the path of the axillary nerve.
Required instruments
Handle for Drill Sleeve 395.911
Drill Sleeve 6.0/5.0 short, with thread 395.921
Drill Sleeve 5.0/3.5, short 395.912
Trocar B 3.5 mm, short 394.181
Precautions:
• Instruments and screws may have sharp edges or
moving joints that may pinch or tear user’s glove
or skin.
• Handle devices with care and dispose worn bone
cutting instruments in an approved sharps con-
tainer.
Required instruments
SELDRILL Schanz Screws B 5.0 mm X94.782–788*
Handle for Drill Sleeve 395.911
Drill Sleeve 6.0/5.0 short, with thread 395.921
Adapter for SELDRILL Schanz Screws B 5.0 mm 393.103
Drill with attachment for AO/ASIF
Quick Coupling type-dependent
Precautions:
• The SELDRILL Schanz screw has been developed
to minimise heat development. Nevertheless, slow
insertion and additional cooling (for example with
a Ringer solution) are recommended.
• The tip of the SELDRILL Schanz screw should be
embedded in the far cortex to effectively resist
cantilever forces and to provide sufficient stability.
1. S
et the drill sleeve assembly
on the bone
Required instruments
Handle for Drill Sleeve 395.911
Drill Sleeve 6.0/5.0 short, with thread 395.921
Drill Sleeve 5.0/3.5, short 395.912
Trocar B 3.5 mm, short 394.181
2. Predrilling
Required instruments
Drill Bit B 3.5 mm, length 195/170 mm, 2-flute,
for Quick Coupling 310.370
Drill with attachment for AO/ASIF
Quick Coupling type-dependent
Required instruments
Self-tapping Schanz Screw X94.520–570*
Handle for Drill Sleeve 395.911
Drill Sleeve 6.0/5.0 short, with thread 395.921
Universal Chuck with T-Handle 393.100
Required instruments
Handle for Drill Sleeve 395.911
Drill Sleeve 6.0/5.0 short, with thread 395.921
Depth Gauge for Schanz Screws 393.780
Universal Chuck with T-Handle 393.100
Precautions:
• Implant sites should be meticulously cared to
avoid pin-tract infection. Schanz screws and
Steinmann pins may be surrounded with antisep-
tic coated foam sponges in an effort to avoid infec-
tion. An implant-site care procedure should be
reviewed with the patient.
• To minimize the risk of pin track infection, the
following points should be observed:
a. Placement of Schanz screws and Steinmann pins
taking anatomy into consideration (ligaments,
nerves, arteries).
b. Slow insertion and/or cooling, particularly in
dense, hard bone to avoid heat necrosis.
c. Release of skin tension at soft tissue entry point
of implant.
2. C
onnect the Schanz screws with
carbon fibre rods
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Combination Clamp, clip-on, self-holding 390.005
Alternative technique:
Required instruments
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Carbon Fibre Rod B 11.0 mm 394.800–870
5. Tighten nuts
Required instruments
Combination Wrench B 11.0 mm 321.160
6. Secondary reduction
A secondary correction of the reduction can be per-
formed within the first few days after surgery. Only the
two combination clamps are released. The correction
can then be made using the partial frames that move
relative to each other.
Precautions:
• Implant sites should be meticulously cared to
avoid pin-tract infection. Schanz screws and
Steinmann pins may be surrounded with antisep-
tic coated foam sponges in an effort to avoid infec-
tion. An implant-site care procedure should be
reviewed with the patient.
• To minimize the risk of pin track infection, the
following points should be observed:
a. Placement of Schanz screws and Steinmann pins
taking anatomy into consideration (ligaments,
nerves, arteries).
b. Slow insertion and/or cooling, particularly in
dense, hard bone to avoid heat necrosis.
c. Release of skin tension at soft tissue entry point
of implant.
B 11.0 mm system
Adult femur
Insert 2–3 Schanz screws into the proximal and distal
main fragment from a lateral direction. With adipose
patients, it is recommendable to use 6.0 mm screws.
The stability of the rod-to-rod assembly can be increased
with an additional neutralization rod.
Unilateral
Insert the screws into the calcaneus and talus from
a medial direction. In the tibia, set the screws at an
anteromedial to medial angle, and connect them using
the rod-to-rod technique.
Triangular
Insert the first screw from an anteromedial direction
into the tibial shaft. Insert the Steinmann pin through
the calcaneus, and affix the rods in the form of a tent
between the first screw and Steinmann pin. Then reduce
the fracture by pulling lengthwise with balanced liga-
mentotaxis. Then insert two screws into the tibia start-
ing from the medial rod. For prophylaxis of pes equines,
insert an additional Schanz screw at an angle from
above into the first and fifth metatarsal bone.
B 8.0 mm system
Humerus
Insert the Schanz screws in the proximal humerus from
a lateral direction and into the distal humerus from a
dorsal direction, avoiding injury to the radial nerve. Con-
nect the Schanz screws using the rod-to-rod technique.
Child femur
Insert 2–3 Schanz screws into the proximal and distal
main fragment from a lateral direction. The stability of
the rod-to-rod assembly can be increased with an addi-
tional neutralization rod.
1. S
et the Schanz screws for
multi pin clamps
Required instruments
SELDRILL Schanz Screws X94.782–788*
Drill Guide Handle, 6 positions 392.963
Drill Sleeve 6.0/5.0, short, with thread 395.921
Drill Sleeve 5.0/3.5, short 395.912
Trocar B 3.5 mm, short 394.181
Drill Sleeve 6.0/5.0 long, with thread 395.923
Drill Sleeve 5.0/3.5, long 395.913
Trocar B 3.5 mm, long 394.182
Adapter for SELDRILL Schanz Screws B 5.0 mm 393.103
Universal Chuck with T-Handle 393.100
Drill with attachment for AO/ASIF
Quick coupling type-dependent
Required instruments
Multi Pin Clamp, 6 positions, large 390.002
Carbon Fibre Rod B 11.0 mm 394.800–870
Combination Wrench B 11.0 mm 321.160
3. Reduction
Due to the clamps that enable the Schanz screws and
carbon-fibre rod to be independently fixed, the fracture
can be optimally reduced using the modular technique
with the double Schanz screws as levers.
Alternative technique:
Required instruments
Reduction Handle for Large Multi Pin Clamp 392.966
Combination Wrench B 11.0 mm 321.160
Wrench, hexagonal B 5.0 mm, long, angled 392.919
4a. U
nilateral single frame with
multi pin clamps
Required instruments
Combination Wrench B 11.0 mm 321.160
Required instruments
Rod Attachment for large Multi Pin Clamp 390.003
Combination Wrench B 11.0 mm 321.160
1. P
rovisionally reduce the fracture,
and set the first Schanz screw
Provisionally reduce the fracture, and insert the first
Schanz screw in a main fragment. From a ventrolateral
direction, locate the first screw as distally as possible.
2. M
ount the carbon fibre rod
and clamp
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Required instruments
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Required instruments
Clamp, clip-on, self-holding 390.008
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Combination Wrench B 11.0 mm 321.160
2. S
etting the second two
Schanz screws
The second Schanz screws to be set on both sides are
introduced somewhat cranially to the first set of screws.
The two tips can slightly converge.
3. Ventral connection
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Clamp, clip-on, self-holding 390.005
Combination Wrench B 11.0 mm 321.160
The rods are held with a combination clamp but are not
tightened.
Required instruments
Combination Wrench B 11.0 mm 321.160
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Clamp, clip-on, self-holding 390.005
Combination Wrench B 11.0 mm 321.160
Required instruments
Connecting Rod B 5.0 mm, Stainless Steel393.900–393.940
Self-tapping Schanz Screw X94.520–570*
Protective Cap, for Schanz Screws and
Steinmann Pins B 5.0 mm 393.420
2. S
etting the second two
Schanz screws
The second screw is set slightly posterior (approximately
2 cm) to the first Schanz screw.
Required instruments
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Clamp, clip-on, self-holding 390.005
Combination Wrench B 11.0 mm 321.160
Self-tapping Schanz Screw X94.520–570*
Protective Cap, for Schanz Screws and
Steinmann Pins B 5.0 mm 393.420
Required instruments
Steinmann Pin B 5.0 mm with trocar tip X93.500–X93.590*
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Protective Cap, for Schanz Screws and
Steinmann Pins B 5.0 mm 393.420
Compressor, open 393.760
Drill Bit B 3.5 mm, length 195/170 mm, 2-flute,
for Quick Coupling 310.370
Required instruments
Steinmann Pin B 5 mm with trocar tip X93.500–X93.590*
Carbon Fibre Rod B 11.0 mm 394.800–394.870
Clamp, clip-on, self-holding 390.008
Combination Wrench B 11.0 mm 321.160
Protective Cap, for Schanz Screws and
Steinmann Pins B 5.0 mm 393.420
Compressor, open 393.760
Drill Bit B 3.5 mm, length 195/170 mm, 2-flute,
for Quick Coupling 310.370
** (TiCP)
** (TAN)
Adapters
Protective caps
Combination wrenches
Drill sleeves
Drill sleeves 6.0 mm (for use with 5.0 mm system)
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Tel: +41 61 965 61 11 All surgical techniques are available as PDF files at
www.jnjmedicaldevices.com www.depuysynthes.com/ifu 0123