The Versatile Polyaxial Solution for the Universal Spine Systems USS II Polyaxial Surgical Technique
Image intensifier control 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. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
Table of Contents USS II Polyaxial 2 AO Spine Principles 4 Intended Use, Indications and Contraindications 5 Implants 6 Instruments 7 Surgical Technique 10 Dismantling Instructions 20 Bibliography 25 USS II Polyaxial Surcical Technique DePuy Synthes 1
USS II Polyaxial USS II Polyaxial combined with USS II Ilio- Sacral enables a construction to be fabricated from the thoracolumbar spine to the pelvis. It is suitable for the treatment of degenerative diseases as well as for correcting deformities. The implants are compatible with all 5 mm and 6 mm rod systems. USS II Polyaxial Versatile Polyaxial Low Profile USS II nut Sleeve 3-D head Click-on head for various combinations Side opening for 5 mm or 6 mm rods 25 deflection Dual-core pedicle and cancellous bone screws Various diameters and lengths Pedicle screws Cancellous bone screws 4.2 5.2 6.2 7.0 8.0 6.2 7.0 8.0 Ease of handling First the screws are inserted and then the polyaxial heads are clicked on the screw. This enables free screw placement. Using the remobilization instrument the polyaxial heads can be remobilized even with the rod in place. 2 DePuy Synthes USS II Polyaxial Surcical Technique
AO Spine Principles The four principles to be considered as the foundation for proper spine patient management underpin the design and delivery of the Curriculum: Stability Alignment Biology Function. 1,2 Stability Stabilization to achieve a specific therapeutic outcome axial sagittal coronal Alignment Balancing the spine in three dimensions Biology Etiology, pathogenesis, neural protection, and tissue healing Function Preservations and restoration of function to prevent disability Copyright 2012 by AOSpine 1 Aebi et al (1998) 2 Aebi et al (2007) 1 DePuy Synthes USS II Polyaxial Surcical Technique
Intended Use, Indications and Contraindications Intended Use The USS II Polyaxial System is a posterior pedicle screw fixation system (T1-S2) designed to provide precise and segmental stabilization of the spine in skeletally mature patients. Indications Degenerative diseases Deformities in combination with USS II or USS Low Profile pedicle screws Fractures and tumours with sufficient anterior support when using USS II Polyaxial as a stand-alone device for posterior fixation Contraindications Fractures and tumors with insufficient anterior support. Precautions: For patients with osteoporosis, the use of cancellous bone screws is recommended. USS II Polyaxial Surcical Technique DePuy Synthes 5
Implants The USS II Polyaxial system consists of the following implants: Pedicle screws Cancellous bone screws Polyaxial 3-D heads Sleeves Pedicle screws with dual core, titanium alloy (TAN) Art. Nos. B Lengths Colour 04.607.010 014* 4.2 mm 20 40 mm gold 04.607.021 027* 5.2 mm 25 55 mm purple 04.607.032 039* 6.2 mm 30 65 mm dark blue 04.607.052 059* 7.0 mm 30 65 mm green 04.607.072 079* 8.0 mm 30 65 mm pink Cancellous bone screws with dual core, titanium alloy (TAN) Art. Nos. B Lengths Colour 04.607.232 239* 6.2 mm 30 65 mm light blue 04.607.252 259* 7.0 mm 30 65 mm turquoise 04.607.260 269* 7.0 mm 70 140 mm turquoise 04.607.272 279* 8.0 mm 30 65 mm dark blue 04.607.280 289* 8.0 mm 70 140 mm dark blue Polyaxial 3-D heads, titanium alloy (TAN) Art. No. For rod B Colour 04.607.401* 5.0 mm light blue 04.607.402* 6.0 mm green Sleeves, titanium alloy (TAN) Art. No. For rod B Colour 04.607.411* 5.0 mm light blue 04.607.412* 6.0 mm green USS II nut, titanium alloy (TAN) Art. No. Colour 499.294* green * All implants are also available sterile packed. Add suffix S to article number. 6 DePuy Synthes USS II Polyaxial Surcical Technique
Instruments The basic instrument set for USS II (187.200) should be used as basic instruments for USS II Polyaxial. Instruments specific for USS II Polyaxial 03.607.001 Screwdriver, bihexagonal 3.0 mm, with T-Handle 03.607.003 USS II Polyaxial Holding Sleeve for No. 03.607.001 03.607.002 Screwdriver Shaft for USS II Polyaxial cancellous bone screws with lengths 70 mm 03.607.006 USS II Polyaxial Handle for Screw Holder 03.607.005 03.607.000 USS II Polyaxial Reamer 03.607.005 USS II Polyaxial Screw Holder USS II Polyaxial Surcical Technique DePuy Synthes 7
Instruments 03.607.004 USS II Polyaxial Positioning Pliers for 3-D Heads 03.607.007 Positioner for Screw Holder 03.607.005 03.607.008 Socket Wrench, bihexagonal 11.0 mm, self-holding, with straight handle 8 DePuy Synthes USS II Polyaxial Surcical Technique
03.607.009 USS II Polyaxial Rod Introduction Pliers for Rods B 6.0 mm and 5.0 mm 03.607.012 USS II Polyaxial Remobilizing Instrument 03.607.013 Stop Sleeve for Remobilizing without Rod 03.607.014 Hollow Reamer B 12.6 mm for USS II Polyaxial Additional instruments 388.143 Socket Wrench 5.0 mm, with T-Handle 388.502 USS Sleeve Pusher (to be used with 03.607.009) 388.584 Socket Wrench for 12-point nut, with L-Handle 388.615 Support for Rod Introduction Pliers USS II Polyaxial Surcical Technique DePuy Synthes 9
Surgical Technique 1. Open pedicles and determine screw lengths Required instruments 388.550 Pedicle Awl B 4.0 mm with Canevasit Handle, length 230 mm, for Pedicle Screws B 5.0 to 7.0 mm 388.540 Pedicle Probe B 3.8 mm, length 230 mm Optional instruments 388.539 Pedicle Probe B 4.8 mm, length 230 mm 388.538 Pedicle Probe B 2.8 mm, length 230 mm 388.551 Pedicle Awl B 3.0 mm, length 230 mm, for Screws B 4.0 mm and 4.2 mm Localize pedicles as described in AO ASIF Principles in Spine Surgery 1. With the Pedicle Awl, open the cortex of the pedicles to a depth of 10 mm. Continue opening the pedicles using the Pedicle Probe B 3.8 mm. Determine the lengths of the USS II Polyaxial screws. Note: If screws B 7.0 mm are implanted as the first screws, use the Pedicle Probe B 4.8 mm. If screws B 4.2 mm are implanted as the first screws, use the Pedicle Probe B 2.8 mm. 1 Aebi, Thalgott, Weber 11 DePuy Synthes USS II Polyaxial Surcical Technique
2. Insert screws into pedicles Required instruments 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 USS II polyaxial cancellous bone screws with lengths 70 mm 03.607.006 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 pedicle until the screw is well seated. Note: If cancellous bone screws with a length of 70 mm or longer are inserted, use the Screwdriver Shaft 03.607.002 attached to the USS II Polyaxial Handle. USS II Polyaxial Surcical Technique DePuy Synthes 11
Surgical Technique 3. Prepare seat for 3-D heads Required instruments 03.607.000 USS II Polyaxial Reamer 03.607.001 Screwdriver, bihexagonal 3.0 mm, with T-Handle Apply the Reamer guided by the Screwdriver over the head of the screw. To ensure free movement of the polyaxial 3-D head, either ream away excessive bone or back-out the screw until the red mark is visible. To ream away bone, move the reamer back and forth until the red mark on the screwdriver shaft becomes visible. Note: Make sure that the Screwdriver is well inserted during the procedure. 11 DePuy Synthes USS II Polyaxial Surcical Technique
4. Insert 3-D heads Required instruments 03.607.005 USS II Polyaxial Screw Holder 03.607.004 USS II Polyaxial Positioning Pliers for 3-D Heads Note: If more than one level has to be fused, it is recommended to check the required curvature of the rod before inserting the 3-D heads. Do so by aligning the Rod Template (388.870, from USS II Basic Instruments) with the screws (see step 5). The technique of head insertion is the same no matter which heads (for B 5.0 mm rods or for B 6.0 mm rods) are used. Insert a Screw Holder into the appropriate 3-D head on the loading station. Make sure that the black markings (flat surface of the Screw Holder) point towards the rod-opening of the 3-D head. Slide the Positioning Pliers over the Screw Holder, and secure them by pulling down the plier handles. With the straight handle, pick up the head and place it onto the screw. Press the pliers to push down the locking ring over the screw head. The 3-D head is now secured but can still be rotated in all directions. Note: Once the 3-D head is secured, it cannot be removed without being destroyed. USS II Polyaxial Surcical Technique DePuy Synthes 11
Surgical Technique 5. Select and insert rods Required instruments 388.440 Holding Forceps for rod B 6 mm, length 290 mm Optional instruments 388.960 Bending Pliers with Rolls for USS Rods B 6 mm, length 300 mm 03.607.006 USS II Polyaxial Handle 03.607.007 Positioner for Screw Holder Determine the length and curvature of the rods. The ± 25 polyaxial flexibility of the screw heads compensates a lateral screw offset up to ± 5.1 mm. If necessary, bend the rods using the Bending Pliers. Notes: Do not bend titanium rods more than 45. Do not bend back and forth. In multilevel cases, bend the rod according to the curvature of the rod template determined in step 4. Insert the rods with the Holding Forceps into the sideopening, polyaxial screw heads. The heads can be manipulated and aligned using the Screw Holder with the Handle 03.607.006. Note: If Screw Holders have to be removed and reinserted during surgery, the Positioner for Screw Holder can be used. If the rod is not inserted yet, apply the Positioner with the slender end over the top of the 3-D head. If rod, sleeve and nut are already inserted, apply the Positioner with the wider end over the 3-D head. 11 DePuy Synthes USS II Polyaxial Surcical Technique
Optional: Align rod and screw head with Rod Introduction Pliers Required instruments 1 388.615 Support for Rod Introduction Pliers 03.607.009 USS II Polyaxial Rod Introduction Pliers 388.502 USS Sleeve Pusher 388.410 Spreader Forceps for USS and Click X, length 330 mm 1 2 If necessary, use the Rod Introduction Pliers to align the rod with a screw head. Never use the Rod Introduction Pliers without guidance provided by the Screw Holder. Following alignment, use the Sleeve Pusher to insert sleeves. Once the sleeve has been inserted with the Sleeve Pusher, the nut can be inserted with the Socket Wrench 388.584 prior to final tightening (step 7). USS II Polyaxial Surcical Technique DePuy Synthes 11
Surgical Technique 6. Insert sleeves and nuts Required instruments 03.607.008 Socket Wrench, bihexagonal 11.0 mm, self-holding, with straight handle 03.607.006 USS II Polyaxial Handle 03.607.005 USS II Polyaxial Screw Holder Use the self-holding Socket Wrench to pick up a sleeve and nut from the loading station. Slide them over the Screw Holder onto the screw head, and tighten the nut slightly. Although the rods are now secured in the sideopening of the screw, the 3-D heads still remain mobile. Note: For constructions with more than two screws on each side, start with the screw heads in the center. 11 DePuy Synthes USS II Polyaxial Surcical Technique
7. Tighten the nuts Required instruments 388.584 Socket Wrench for 12-point nut, with L-Handle 388.143 Socket Wrench 5.0 mm, with T-Handle 03.607.005 USS II Polyaxial Screw Holder Optional Instruments 03.602.042 Torque-limiting Handle 12 Nm Use the Socket Wrench with L-Handle to final tighten the nuts. Counteract torque using the Socket Wrench with T-Handle placed over the Screw Holder. Make sure to firmly tighten all nuts. Note: It is necessary to apply a tightening moment of 12 Nm to secure the polyaxial screw heads tightly. To achieve this, the Torque-limiting handle 12 Nm (03.602.042) may be used instead of the Socket Wrench. Remove the Screw Holders when all the screws are finally tightened. USS II Polyaxial Surcical Technique DePuy Synthes 11
Surgical Technique 8. Remobilization and/or removal Required instruments 03.607.008 Socket Wrench, bihexagonal 11.0 mm, self-holding, with straight handle 03.607.012 USS II Polyaxial Remobilizing Instrument 03.607.013 Stop Sleeve for Remobilizing without Rod 03.607.014 Hollow Reamer B 12.6 mm for USS II Polyaxial 03.607.005 USS II Polyaxial Screw holder Note: Always apply the Screw Holder as a guide. In the following situations, the USS II Polyaxial heads can be remobilized with the Remobilizing Instrument: 1. Head with rod introduced Loosen the nut with the Socket Wrench as far as possible. Then slide the Remobilizing Instrument over the screw head (make sure the red mark on the shaft with the T-Handle is visible), and push the outer sleeve down. Turn the T-Handle until it stops. The head is now mobile again. Note: Once the polyaxial head is secured, if it is removed a new polyaxial head will be needed. 11 DePuy Synthes USS II Polyaxial Surcical Technique
2. Head without rod Apply the Stop Sleeve over the polyaxial head. Then apply the Remobilizing Instrument as described before. Note: If the head has to be removed, remove nut and sleeve using the Socket Wrench. Remove the rods. Apply the Remobilizing Instrument as described above without inserting the Stop Sleeve. This is how the locking ring will be completely removed. Then remove the polyaxial head with the Screw Holder. Note: If the use of the Remobilizing instrument is hindered by bone touching the polyaxial screw head, use the Hollow Reamer, guided by the Screw Holder, to remove excessive bone first. USS II Polyaxial Surcical Technique DePuy Synthes 11
Dismantling Instructions 03.607.005 USS II Polyaxial Screw Holder 1 1 2 2 22 DePuy Synthes USS II Polyaxial Surcical Technique
03.607.003 USS II Polyaxial Holding Sleeve for 03.607.001 1 1 2 2 2 1 3 4 5 USS II Polyaxial Surcical Technique DePuy Synthes 22
Dismantling Instructions 03.607.002 Screwdriver Shaft for USS II Polyaxial cancellous bone screws with lengths 70 mm 1 2 1 2 22 DePuy Synthes USS II Polyaxial Surcical Technique
03.607.012 USS II Polyaxial Remobilizing Instrument 1 2 1 2 3 USS II Polyaxial Surcical Technique DePuy Synthes 22
Dismantling Instructions 03.607.006 USS II Polyaxial Handle for Screw Holder 03.607.005 1 2 3 4 5 22 DePuy Synthes USS II Polyaxial Surcical Technique
Bibliography Aebi M, Thalgott JS, Webb JK (1998) AO ASIF Principles in Spine Surgery. Berlin: Springer Aebi M, Arlet V, Webb JK (2007): AOSPINE Manual (2 vols), Stuttgart, New York: Thieme. USS II Polyaxial Surcical Technique DePuy Synthes 22
Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 www.depuysynthes.com Not all products are currently available in all markets. This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at www.depuysynthes.com/ifu 0123 DePuy Synthes Spine, a division of Synthes GmbH. 2016. All rights reserved. 036.000.216 DSEM/SPN/0115/0260(1) 10/16