Synthes USS II User manual

Polyaxial Screws for the Thoracolumbar Spine
USS™II Polyaxial
Spine System
Surgical Technique

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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

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 1
Table of Contents
Introduction USSTM II Polyaxial Spine System 2
AO Spine Principles 3
Surgical Technique Open pedicles and determine screw lengths 4
Insert screws into pedicles 5
Prepare seat for Polyaxial 3-D heads 6
Insert 3-D heads 7
Select and insert rods 8
Insert sleeves and nuts 10
Tighten the nuts 11
Remobilization and/or removal 12
Indications and Contraindications 14
Bibliography 15
*For product catalog contact your local DePuy Synthes representative.

2 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
Overview
USS™ II Polyaxial Spine System combined with USS II Ilio-Sacral Spine
System is designed for fixation of the thoracolumbar spine and the
pelvis.
USSTM II Polyaxial Spine System
4.2 5.2 6.2 7.0 8.0 6.2 7.0 8.0
Pedicle screws
Cancellous
bone screws
USS II nut
Sleeve
Polyaxial 3-D head
• Click-on head
• Side opening for 5 mm or 6 mm rods
• 25° deection
Dual-core pedicle and cancellous
bone screws
• Various diameters and lengths

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 3
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
AO Spine Principles
Stability
Stabilization to achieve a
specic therapeutic
outcome
Alignment
Balancing the spine in
three dimensions
Biology
Etiology, pathogenesis,
neural protection,
and tissue healing
Function
Preservations and resto-
ration of function to pre-
vent disability
Copyright © 2012 by AOSpine

4 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
Surgical Technique
1. Open pedicles and determine
screw lengths
Required instruments
388.550 Pedicle Awl Ø4.0 mm with Canevasit
Handle, length 230 mm, for Pedicle
Screws Ø5.0 to 7.0 mm
388.540 Pedicle Probe Ø3.8 mm with Canevasit
Handle, length 230 mm, for Pedicle
Screws Ø5.0 to 7.0 mm
Optional instruments
388.539 Pedicle Probe Ø4.8 mm with Canevasit
Handle, length 230 mm, for Pedicle
Screws Ø8.0 and 9.0 mm
388.538 Pedicle Probe Ø2.8 mm,
length 230 mm
388.551 Pedicle Awl Ø3.0 mm, length 230 mm,
for Screws Ø4.0 mm and 4.2 mm
With the Pedicle Awl, open the cortex of the pedicles by
inserting the awl until the shoulder of the awl contacts
the bone. Continue opening the pedicles using the
Pedicle Probe Ø3.8 mm.
Determine the lengths of the USS II Polyaxial screws.
Note: If screws Ø7.0 mm are implanted as the rst
screws, use the Pedicle Probe Ø4.8 mm. If screws
Ø4.2 mm are implanted as the rst screws, use the
Pedicle Probe Ø2.8 mm.

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 5
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.
Precaution: For patients with suboptimal bone qual-
ity, the use of cancellous bone screws is recom-
mended.
Surgical Technique

6 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
3. Prepare seat for Polyaxial
3-D heads
Required instruments
03.607.000 Reamer for USS II Polyaxial
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 poly-
axial 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.
Surgical Technique

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 7
Surgical 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
Precaution: 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 Ø5.0 mm rods or for Ø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
(at 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.
Warning: Once the polyaxial head is secured, if it is
removed a new polyaxial head must be used.

8 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
5. Select and insert rods
Required instruments
388.440 Holding Forceps with broad Tip,
length 290 mm, for Rods Ø6.0 mm
Optional instruments
388.960 Bending Pliers with Rolls for USS Rods
Ø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 exibility of the screw heads equates to a
lateral screw offset up to ±5.1 mm. If necessary, bend
the rods using the Bending Pliers.
Warning: Do not bend titanium rods more than 45°.
Do not bend back and forth.
Notes: 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 side-
opening, 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 re-
inserted 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.
Surgical Technique

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 9
Optional: Align rod and screw head with Rod
Introduction Pliers
Required instruments
388.615 Counter Torque 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
If necessary, use the Rod Introduction Pliers to align the
rod with a screw head.
Precaution: 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).
Surgical Technique
1
1
2

10 DePuy Synthes USS™ II Polyaxial Spine System 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 side-
opening 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 cen-
ter.
Surgical Technique

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 11
7. Tighten the nuts
Required instruments
388.584 Socket Wrench for twelve 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.
Precaution: Make sure to rmly 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.
Surgical Technique

12 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
8. Remobilization and/or removal
Required instruments
03.607.008 Socket Wrench, bihexagonal 11.0 mm,
self-holding, with straight handle
03.603.108 Remobilization Tool for USS II Polyaxial
03.607.013 Stopping 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
Precaution: 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 possi-
ble. 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.
Warning: Once the polyaxial head is secured, if it is
removed a new polyaxial head must be used.
Surgical Technique

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 13
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 rst.
Surgical Technique

14 DePuy Synthes USS™ II Polyaxial Spine System Surgical Technique
Indications and Contraindications
Please refer to the corresponding Instructions for Use for
specific information on Intended use, Indications,
Contraindications, Warnings and Precautions, Potential
Adverse Events, Undesirable Side Effects and Residual
Risks. Instructions for Use are available at www.e-ifu.
com and/or www.depuysynthes.com/ifu.

Surgical Technique USS™ II Polyaxial Spine System DePuy Synthes 15
1 Aebi M, Arlet V, Webb JK, (2007): AOSPINE Manual
(2 vols), Stuttgart, New York: Thieme.
2 Aebi M, Thalgott JS, Webb JK (1998): AO ASIF
Principles in Spine Surgery. Berlin: Springer.
Bibliography

Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
Tel: [phone]
www.JnJMedicalDevices.com
Not all products are currently available in all markets.
This publication is not intended for distribution in the USA.
Surgical techniques are available as PDF files at
www.depuysynthes.com/ifu © DePuy Synthes Spine, a division of Johnson & Johnson Medical Ltd. 2021. All rights reserved. SE_826386 (036.000.216; DSEM/SPN/0115/0260) EOS: 169843-210309. EMEA 03/21