USS II ILIO-SACRAL Modular System for Stable Fixation in the Sacrum and Illium

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1 USS II ILIO-SACRAL Modular System for Stable Fixation in the Sacrum and Illium Instruments and implants approved by the AO Foundation. This publication is not intended for distribution in the USA. TECHNIQUE GUIDE

2 Warning This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to:

3 TABLE OF CONTENTS INTRODUCTION USS II Ilio-Sacral 2 Indications and Contraindications 4 PRODUCT INFORMATION Implants 5 Instruments 7 SURGICAL TECHNIQUE Iliac Fixation with Iliac Connector 9 S2 Fixation with S2 Connector 18 Insertion S2 connector left/right 21 Insertion S2 connector for rod end 23 Remobilisation of the Polyaxial Connection for Implant Removal 25 USS II Ilio-Sacral Technique Guide DePuy Synthes 1

USS II ILIO-SACRAL USS II Ilio-Sacral is intended for an additional rod fixation in the ilium and in S2.

There are different connectors available for the linkage to the ilium and to the S2 pedicle.

4 USS II ILIO-SACRAL USS II Ilio-Sacral is intended for an additional rod fixation in the ilium and in S2. It is an add-on to USS II Polyaxial and combined with the USS systems enables a construct from the thoracolumbar spine to the pelvis. There are different connectors available for the linkage to the ilium and to the S2 pedicle. All connectors are combined with the USS II Polyaxial bone screws. USS II Ilio-Sacral USS II nut Add-on to USS II Polyaxial Uses the same bone screws (extra long up to 140 mm) Low profile Fixed length iliac connector (1) Telescopic iliac connector (2) Clamp for fixed length/ telescopic iliac connector 1 2 Collet Dual-core cancellous bone screws S2 connector, left/right S2 connector, for rod end Pelvic connectors Pelvic rod Secure working over sticks, for both USS II Ilio-Sacral and USS II Polyaxial. S2 fixation 2 DePuy Synthes USS II Ilio-Sacral Technique Guide

6 INDICATIONS AND CONTRAINDICATIONS Notes The iliac connectors provide additional stabilization for an S1 screw fixation. It is recommended to always combine an iliac connector with an S1 screw. For degenerative diseases, it is recommended to use an S2 fixation where possible in addition to the S1 screw. Indications USS II Ilio-Sacral is indicated for fixation of long posterior rod constructs in the ilium and in S2, both in combination with an S1 fixation. S1 fixation combined with iliac fixation: Severe scoliosis (e.g. neuromuscular) S1 fixation combined with S2 fixation: Degenerative diseases (e.g. spondylolisthesis) Contraindications Fractures and tumours with insufficient anterior support USS II Ilio-Sacral should not be used where no fixation in S1 is possible. 4 DePuy Synthes USS II Ilio-Sacral Technique Guide

IMPLANTS Iliac connectors, fixed length 04.621.112 145* Iliac connectors in fixed lengths from 12 to 45 mm (in 3 mm steps) 04.621.275* Clamp for iliac connector with fixed length Iliac connector, telescopic 04.

0 mm 04.621.262* S2 connector for rod end, for rods 6 mm Collet for iliac connector and S2 connector 04.621.190* Collet for iliac connector and S2 connector, for all sizes * All implants are also available sterile packed.

7 IMPLANTS Iliac connectors, fixed length * Iliac connectors in fixed lengths from 12 to 45 mm (in 3 mm steps) * Clamp for iliac connector with fixed length Iliac connector, telescopic * Iliac connector, telescopic, neutral, length mm * Clamp for telescopic iliac connector S2 connectors /261* S2 connector, left/right, for rods 6.0 mm * S2 connector for rod end, for rods 6 mm Collet for iliac connector and S2 connector * Collet for iliac connector and S2 connector, for all sizes * All implants are also available sterile packed. Add suffix S to article number. USS II Ilio-Sacral Technique Guide DePuy Synthes 5

8 Implants USS II nut * USS II nut USS II Polyaxial cancellous bone screws with dual core Art. Nos. Lengths Colour * 6.2 mm mm light blue * 7.0 mm mm turquoise * 8.0 mm mm blue Optionally USS II Polyaxial pedicle screws can be used. Pelvic connectors* * L-connector * Claw-connector * T-connector, small * T-connector, large Pelvic rods* Pelvic rod, left Pelvic rod, right * Implants are also available sterile packed. Add suffix S to article number. 6 DePuy Synthes USS II Ilio-Sacral Technique Guide

9 INSTRUMENTS The USS General Instruments ( ) are recommended for use as basic instrument set. USS II Polyaxial instruments needed for USS II Ilio-Sacral Screwdriver, bihexagonal 3.0 mm, with T-Handle USS II Polyaxial Holding Sleeve for No Screwdriver Shaft for USS II Polyaxial cancellous bone screws with lengths M70 mm Handle for Screw Holder or USS II Polyaxial Handle for Screw Holder USS II Polyaxial Reamer USS II Ilio-Sacral Technique Guide DePuy Synthes 7

Instruments 03.607.005 USS II Polyaxial Screw Holder 388.584 Socket Wrench for twelve point nut, with L-Handle USS II Ilio-Sacral instruments 03.621.011 Clamp Holder (for clamps 04.621.270 and 275) 03.

10 Instruments USS II Polyaxial Screw Holder Socket Wrench for twelve point nut, with L-Handle USS II Ilio-Sacral instruments Clamp Holder (for clamps and 275) Templates for Iliac Connectors (short, medium, long) Socket Wrench, cannulated, with Straight Handle for USS-II Nut Additional instruments Depth Gauge for Pedicle Screws, measuring range up to 110 mm Socket Wrench 5.0 mm, with T-Handle Screwdriver, hexagonal, small, 2.5 mm, with Groove 8 DePuy Synthes USS II Ilio-Sacral Technique Guide

ILIAC FIXATION WITH ILIAC CONNECTOR 1 Instrument spine down to S1 Instrument the spine with a rod construct down to S1 according to the surgical technique of the implant system used (e.g. USS II Polyaxial).

11 ILIAC FIXATION WITH ILIAC CONNECTOR 1 Instrument spine down to S1 Instrument the spine with a rod construct down to S1 according to the surgical technique of the implant system used (e.g. USS II Polyaxial). In S1, it is recommended to use a USS II Polyaxial cancellous bone screw for easy rod introduction. Note: Leave at least 3 cm excess rod caudally to the S1 screw for later placement of the iliac connector. Alternative Instead of applying the iliac connectors to the rod as the last step in the surgery, it is also possible to insert all screws and iliac connectors first, and then apply the rod. 2 Determine size of iliac connector Templates (short, medium, long) Use the templates to determine the proper implant size. Either the telescopic or the fixed-length iliac connector may be used. Notes Fixed length connector: The distances indicated on the template correspond to the implant size (mm). Telescopic connector: The distance varies between 17 and 27 mm. USS II Ilio-Sacral Technique Guide DePuy Synthes 9

Iliac Fixation with Iliac Connector 3 Attach clamp Required instrument 03.621.

twice as long as the USS II Polyaxial Screw Holder. Attach the clamp to the rod from the midline.

12 Iliac Fixation with Iliac Connector 3 Attach clamp Required instrument Clamp Holder Pick up the corresponding clamp for the telescopic or fixed-length connector from the tray using the Clamp Holder. Note: The Clamp Holder is approx. twice as long as the USS II Polyaxial Screw Holder. Attach the clamp to the rod from the midline. If necessary, remove excessive bone below the rod to create enough space for the clamp. Clamp for fixed-length iliac connector Clamp for telescopic iliac connector Note: To prevent possible tissue irritation remove enough bone on the ilium so that the iliac connector will be seated below the original iliac crest. 11 DePuy Synthes USS II Ilio-Sacral Technique Guide

4 Place iliac connector and create screw entry point Required instrument 03.621.011 Clamp Holder Drop the iliac connector over the Clamp Holder.

13 4 Place iliac connector and create screw entry point Required instrument Clamp Holder Drop the iliac connector over the Clamp Holder. With the implant in place, verify that the correct implant size has been chosen. Use a pedicle probe to drill the screw hole in the center of the opening of the iliac connector. This ensures that the screw will be placed at the correct distance to the rod. After drilling the screw hole, remove the iliac connector. Alternative screw placement in the ilium: The screw may be placed from the inner side of the iliac crest in order to reduce the extent of soft tissue exposure. USS II Ilio-Sacral Technique Guide DePuy Synthes 11

Iliac Fixation with Iliac Connector 5 Insert bone screw 03.607.001 Screwdriver, bihexagonal 3.0 mm, with T-Handle 03.607.003 USS II Polyaxial Holding Sleeve Optional instruments 03.607.002 Screwdriver Shaft for screws M70 mm 03.

14 Iliac Fixation with Iliac Connector 5 Insert bone screw Screwdriver, bihexagonal 3.0 mm, with T-Handle USS II Polyaxial Holding Sleeve Optional instruments Screwdriver Shaft for screws M70 mm USS II Polyaxial Handle Pick up the appropriate screw from the screw rack using the Screwdriver and the Holding Sleeve. Insert the screw into the prepared ilium until the screw is well seated. Note: For cancellous bone screws with a length of 70 mm or longer, use the Screwdriver Shaft attached to the USS II Polyaxial Handle. 11 DePuy Synthes USS II Ilio-Sacral Technique Guide

6 Expose screw head 03.607.000 USS II Polyaxial Reamer 03.607.001 Screwdriver, bihexagonal 3.0 mm, with T-Handle Place the Reamer guided by the Screwdriver over the screw head.

15 6 Expose screw head USS II Polyaxial Reamer Screwdriver, bihexagonal 3.0 mm, with T-Handle Place the Reamer guided by the Screwdriver over the screw head. Ream away excessive bone by moving the reamer back and forth until the red mark on the screwdriver shaft becomes visible. Note: If more bone that may block the connector has to be removed, use a chisel or gauge pliers. USS II Ilio-Sacral Technique Guide DePuy Synthes 11

Iliac Fixation with Iliac Connector 7 Click on the collet 03.607.005 USS II Polyaxial Screw Holder 03.607.006 USS II Polyaxial Handle (388.

Click on the collet and orient the notch on the collet in direction of the screw angulation to achieve larger angles.

16 Iliac Fixation with Iliac Connector 7 Click on the collet USS II Polyaxial Screw Holder USS II Polyaxial Handle ( ) (Handle for Screw Holder) Use the USS II Polyaxial Screw Holder to pick up a collet from the tray. Optionally, attach the Handle for a better hold. Click on the collet and orient the notch on the collet in direction of the screw angulation to achieve larger angles. Afterwards release the Handle leaving the Screw Holder attached to the collet. Note: Make sure that no tissue is stuck between the screw head and the collet. 11 DePuy Synthes USS II Ilio-Sacral Technique Guide

8 Insert iliac connector 03.621.011 Clamp Holder Attach the clamp to the rod from the midline.

17 8 Insert iliac connector Clamp Holder Attach the clamp to the rod from the midline. Slide the iliac connector over both the Clamp Holder and the Screw Holder. USS II Ilio-Sacral Technique Guide DePuy Synthes 11

Iliac Fixation with Iliac Connector 9 Lock iliac connector 03.621.012 Socket Wrench, cannulated, with Straight Handle for USS-II Nut 388.

0 mm, with T-Handle 1 2 Pick up a nut using the Socket Wrench with Straight Handle (black), place it over the collet of the iliac screw and tighten it slightly.

This is how the iliac connector is firmly attached to the bone screw while the polyaxiality is still maintained.

18 Iliac Fixation with Iliac Connector 9 Lock iliac connector Socket Wrench, cannulated, with Straight Handle for USS-II Nut Socket Wrench for twelve point nut, with L-Handle Socket Wrench 5.0 mm, with T-Handle 1 2 Pick up a nut using the Socket Wrench with Straight Handle (black), place it over the collet of the iliac screw and tighten it slightly. (1) Notes Always first place a nut on the collet (iliac screw) and then one on the clamp (rod). Pre-tighten the nut on the iliac screw at least 2 revolutions. This is how the iliac connector is firmly attached to the bone screw while the polyaxiality is still maintained. Pull on the Screw Holder to check if the collet has been attached correctly. Secondly, apply a nut on the clamp, and tighten it slightly. (2) For final tightening, change the Socket Wrench with black handle to the one with L-Handle. Use the Socket Wrench with T-Handle as counter-torque. 11 DePuy Synthes USS II Ilio-Sacral Technique Guide

Optional: Lock the clamp of the connector with the Spreader Forceps 388.410 Spreader Forceps 388.

19 Optional: Lock the clamp of the connector with the Spreader Forceps Spreader Forceps Support for Rod Introduction Pliers (Clip for Persuader) In some cases, the iliac connector may not be properly seated on the rod, and the nut cannot be tightened. In this case, use the technique described below. With the Socket Wrench with L-Handle in place, attach the Clip for Persuader at the distal end of the Clamp Holder. Press the Spreader Forceps. This will pull up the clamp. At the same time, turn the Socket Wrench until the nut engages. USS II Ilio-Sacral Technique Guide DePuy Synthes 11

S2 FIXATION WITH S2 CONNECTOR 1 Instrument spine down to S1 Place the pedicle screws according to the surgical technique of the system used (e.g. USS II Polyaxial) 2 Prepare hole for the S2 pedicle screw 388.

20 S2 FIXATION WITH S2 CONNECTOR 1 Instrument spine down to S1 Place the pedicle screws according to the surgical technique of the system used (e.g. USS II Polyaxial) 2 Prepare hole for the S2 pedicle screw Pedicle probe 3.8 mm with Canevasit Handle Pedicle probe 4.8 mm with Canevasit Handle Open the pedicle using a pedicle probe. 11 DePuy Synthes USS II Ilio-Sacral Technique Guide

3 Insert S2 screw 03.607.001 Screwdriver, bihexagonal 3.0 mm, with T-Handle 03.607.003 USS II Polyaxial Holding Sleeve Pick up the appropriate screw from the screw rack using the Screwdriver and the Holding Sleeve.

001 Screwdriver, bihexagonal 3.0 mm, with T-Handle 03.607.000 USS II Polyaxial Reamer Place the Reamer guided by the Screwdriver over the screw head.

21 3 Insert S2 screw Screwdriver, bihexagonal 3.0 mm, with T-Handle USS II Polyaxial Holding Sleeve Pick up the appropriate screw from the screw rack using the Screwdriver and the Holding Sleeve. Insert the screw into the prepared pedicle until the screw is well seated. Ideally, the screw is placed bicortically. 4 Expose screw head Screwdriver, bihexagonal 3.0 mm, with T-Handle USS II Polyaxial Reamer Place the Reamer guided by the Screwdriver over the screw head. Ream away excessive bone by moving the reamer back and forth until the red mark on the screwdriver shaft becomes visible. USS II Ilio-Sacral Technique Guide DePuy Synthes 11

S2 Fixation with S2 Connector 5 Click on the collet 03.607.005 USS II Polyaxial Screw Holder 388.622 Handle for Screw Holder (03.607.006) (USS II Polyaxial Handle) Use the USS II Polyaxial Screw Holder to pick up a collet from the tray.

22 S2 Fixation with S2 Connector 5 Click on the collet USS II Polyaxial Screw Holder Handle for Screw Holder ( ) (USS II Polyaxial Handle) Use the USS II Polyaxial Screw Holder to pick up a collet from the tray. Optionally, attach the Handle for a better hold. Click on the collet and orient the notch on the collet in direction of the screw angulation to achieve larger angles. Afterwards release the Handle leaving the Screw Holder attached to the collet. Notes Make sure that no tissue is stuck between the screw head and the collet. Alternatively a USS II Polyaxial 3-D head may be clicked on the screw instead of using the S2 c o n n e c t o r. 22 DePuy Synthes USS II Ilio-Sacral Technique Guide

Insertion S2 connector left/right 6a Insert S2 connector (left or right) 388.584 Socket Wrench for twelve point nut, with L-Handle 03.607.

Pick up a nut using the Socket Wrench with L-Handle, and place it over the collet of the S2 screw.

23 Insertion S2 connector left/right 6a Insert S2 connector (left or right) Socket Wrench for twelve point nut, with L-Handle USS II Polyaxial Screw Holder Slide the connector over the Screw Holder onto the collet. Pick up a nut using the Socket Wrench with L-Handle, and place it over the collet of the S2 screw. Pre-tighten the nut on the S2 screw at least two revolutions. This is how the S2 connector is firmly attached to the bone screw while the polyaxiality is still maintained. Check for a secure seat by pulling on the Screw Holder. USS II Ilio-Sacral Technique Guide DePuy Synthes 22

S2 Fixation with S2 Connector 7a Insert rod and lock nuts 03.607.005 USS II Polyaxial Screw Holder 388.584 Socket Wrench for twelve point nut, with L-Handle 388.143 Socket Wrench 5.

24 S2 Fixation with S2 Connector 7a Insert rod and lock nuts USS II Polyaxial Screw Holder Socket Wrench for twelve point nut, with L-Handle Socket Wrench 5.0 mm, with T-Handle Screwdriver, bihexagonal 3.0 mm, with T-Handle Insert the rod into the connector. Connect the rod to the remaining screws according to the surgical technique of the implant system used (e.g. USS II Polyaxial). Use the Screwdriver to lock the set screw on the S2 connector. Use the Socket Wrench with T-Handle as counter-torque for final tightening. 22 DePuy Synthes USS II Ilio-Sacral Technique Guide

Insertion S2 connector for rod end 6b Insert connector for rod end Required instrument 314.070 Screwdriver, hexagonal, small, 2.

25 Insertion S2 connector for rod end 6b Insert connector for rod end Required instrument Screwdriver, hexagonal, small, 2.5 mm, with Groove Insert contoured rod into the connector and lock the set screw with the 2.5 mm Screwdriver. Slide the connector over the Screw Holder onto the collet. Pick up a nut using the Socket Wrench with L-Handle and place it over the collet of the S2 screw. Pre-tighten the nut on the S2 screw at least two revolutions. This is how the S2 connector is firmly attached to the bone screw while the polyaxiality is still maintained. Check for a secure seat by pulling on the Screw Holder. USS II Ilio-Sacral Technique Guide DePuy Synthes 22

S2 Fixation with S2 Connector 7b Connect rod to remaining screws and lock nuts 03.607.005 USS II Polyaxial Screw Holder 388.584 Socket Wrench for twelve point nut, with L-Handle 388.

26 S2 Fixation with S2 Connector 7b Connect rod to remaining screws and lock nuts USS II Polyaxial Screw Holder Socket Wrench for twelve point nut, with L-Handle Socket Wrench 5.0 mm, with T-Handle Connect the rod to the remaining screws according to the surgical technique of the implant system used (e.g. USS II Polyaxial). Use the Socket Wrench with T-Handle as counter-torque for final tightening. 22 DePuy Synthes USS II Ilio-Sacral Technique Guide

REMOBILISATION OF THE POLYAXIAL CONNECTION FOR IMPLANT REMOVAL 388.584 Socket Wrench for twelve point nut, with L-Handle 03.607.

27 REMOBILISATION OF THE POLYAXIAL CONNECTION FOR IMPLANT REMOVAL Socket Wrench for twelve point nut, with L-Handle USS II Polyaxial Screw Holder USS II Polyaxial Handle After removing the nuts, move the collet back and forth using the Screw Holder. The collet will come loose. USS II Ilio-Sacral Technique Guide DePuy Synthes 22

28 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes Spine, a division of Synthes GmbH All rights reserved DSEM/SPN/0115/ /15

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