hcs 4.5/6.5. the countersinkable compression screw.synthes.vo.llnwd.net/o16/llnwmb8/int...

HCS 4.5/6.5. The countersinkable compression screw.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

HCS 4.5/6.5 Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information 26

HCS 4.5/6.5 2

Indications 4

Surgical Technique for HCS 4.5 and 6.5* 5

Screw Extraction 15

Implants – HCS 4.5 16

Instruments – HCS 4.5 18

Implants – HCS 6.5 21

Instruments – HCS 6.5 23

* illustrated using HCS 4.5

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 MaintenanceFor 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-maintenanceFor 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

2 DePuy Synthes HCS 4.5/6.5 Surgical Technique

Self-drilling and self-tapping tipShort and efficient surgical technique

CannulationFor minimally invasive technique and guided insertion

Reverse-cutting flutesFacilitate screw removal and prevent potential breaking of implant

Cutting flutesFacilitate countersinking of the screw head

Identical pitch of head and shaft threadsFor controlled closure and compression of the fracture gap

Two different thread lengths of the shaftThe optimal implant for every case due to threads available in different lengths

Available in steel and titaniumAll headless compression screws from Synthes are available in stainless implant-grade steel and high-quality biocompatible titanium alloy (TAN)

HCS 4.5/6.5. The countersinkable compression screw.

Features and benefits


Functional principle: Lag screw technique with compression sleeve

Step 1:Screw insertionInsert the screw into the bone with the compression sleeve.

Step 2:Closure of gap and compressionOnce the tip of the compression sleeve lies on the bone, the fracture gap is closed and compressed by turning the sleeve.

Step 3:CountersinkingOnce the desired degree of compres-sion is reached, the screw is counter-sunk into the bone with the screw-driver while the compression sleeve is held stationary. During countersinking, no additional compression is gener-ated.


Indications

HCS 4.5Fracture, osteoarthritis, or deformity of small to large bones.

Examples: – Calcaneus – Talus – Metatarsus – Distal and proximal tibia – Distal femur – Proximal humerus

HCS 6.5Fracture, osteoarthritis, or deformity of small to large bones.

Examples: – Calcaneus – Talus – Distal and proximal tibia – Distal femur


Surgical Technique for HCS 4.5 and 6.5

1Insert the guide wire

Instruments

HCS 4.5

02.226.000 Guide Wire B 1.6 mm, length 220 mmor02.226.001 Guide Wire B 1.6 mm with trocar tip, length 220 mm, Stainless Steel

312.770 Protection Sleeve 9.5/7.0

312.760 Drill Sleeve 7.0/3.2

312.750 Drill Sleeve 3.2/1.6

312.740 Trocar B 1.6 mm

HCS 6.5

292.680 Guide Wire B 2.8 mm, length 300 mmor02.227.001 Guide Wire B 2.8 mm with trocar tip, length 300 mm, Stainless Steel



312.080 Drill Sleeve 8.5/2.8

312.020 Trocar B 2.8 mm

After a stab incision, advance the drill sleeve assembly through the soft tissues until it reaches the bone.

While monitoring with the image intensifier, advance the guide wire through the drill sleeve assembly until the thread tip is anchored in the far cortex of the bone.

Precaution: Do not forcefully insert the guide wire as it may cause bending.



2Determine screw and thread length

Instruments

HCS 4.5

03.226.030 Direct Measuring Device for HCS 4.5


HCS 6.5

03.227.030 Direct Measuring Device for HCS 6.5



Remove the drill sleeve. Slide the narrow end of the measur-ing device through the protection sleeve and over the guide wire until it reaches the bone.

The measurement on the measuring device shows the depth in millimeters of the guide wire in the bone. This depth indi-cates the appropriate screw length.

Note: Only use the guide wire in its prescribed length to en-sure correct measurement. If the screw is to be countersunk below the surface of the bone, subtract the appropriate screw length. If a large fracture gap needs to be closed, sub-tract more.


The position of the fracture line determines the thread length:

Correct thread lengthThe shaft thread lies below the fracture gap and completely within the distal fragment during compression. Fragments can be compressed.

Incorrect thread lengthThe shaft thread lies above the fracture gap or the osteotomy. Fragments cannot be compressed.



3Predrilling

Instruments

HCS 4.5

03.226.039 Drill Bit B 3.2 mm, cannulated


312.760 Drill Sleeve 7.0/3.2

HCS 6.5

310.630 Drill Bit B 5.0 mm, cannulated



Predrilling facilitates the insertion of the screw in dense bone.

Insert the drill sleeve in the protection sleeve. Slide the cannulated drill bit over the guide wire and predrill to the desired depth.

Remove the drill sleeve and verify the appropriate drilling depth with the image intensifier.

Precaution: Avoid forcefully advancing or bending the drill bit as this may cause the drill bit to break. Do not advance the drill bit beyond the wire. When drilling is complete, slowly pull the drill bit straight out while running the power tool in “forward mode” to ensure the guide wire stays in place.


90°

4Option: Predrilling for head

Instruments

HCS 4.5

03.226.042 Drill Bit for predrilling for screw head, cannulated, for HCS 4.5


HCS 6.5

03.227.042 Drill Bit for predrilling for screw head, cannulated, for HCS 6.5



The corticalis can be predrilled with the drill bit to facilitate head insertion in dense bone and to prevent the bone from cracking.

Slide the drill bit with the protection sleeve over the guide wire and carefully predrill the corticalis.

Note: The depth of predrilling depends on the inclination of the guide wire to the bone. It is necessary to predrill only to the first marking in cases where angulation is ± 90°. An angulation of ± 45° requires a deeper predrilling to the second marking.


Surgical Technique for HCS 4.5 & 6.5

5Pick up screw

Instruments

HCS 4.5

03.226.033 Compression Sleeve for HCS 4.5

319.970 Screw Forceps, self-holding, length 85 mm

HCS 6.5



To remove a screw from the screw rack, pick it up with the screw forceps and twist the compression sleeve over the head of the screw.

Note: Do not remove the screw with the compression sleeve directly from the screw rack. The screw rack could be damaged.

6Insert screw and compress fragments

Instruments

HCS 4.5


03.226.037 Handle for Compression Sleeve for HCS 4.5


03.226.038 Attachment for Compression Sleeve for HCS 4.5


HCS 6.5


03.227.037 Handle for Compression Sleeve for HCS 6.5


03.227.038 Attachment for Compression Sleeve for HCS 6.5

Slide the compression sleeve handle into the compression sleeve. Insert the screw assembly over the guide wire. Insert the screw into the bone by turning the compression sleeve until the fracture gap or the osteotomy is closed and com-pressed.

Option: Screw insertion can also be performed with the use of a power drill. Slide the attachment for compression sleeve into the compression sleeve and connect it to the power drill

Precaution: Insert the screw into the bone and stop before the compression sleeve touches the bone. Close and com-press manually by using the handle.



Optional instruments

for use with 4.5 mm screws

03.226.034 Sleeve for Compression Sleeve for HCS – Headless Compression Screw B 4.5 mm

for use with 6.5 mm screws


In osteoporotic bone, an additional sleeve should be placed over the compression sleeve before compressing the fracture or osteotomy to prevent the compression sleeve from pierc-ing the cortex.

Note: Verify the correct position of the shaft thread in the distal fragment using the image intensifier. If the thread lies over the fracture gap or the osteotomy, the gap cannot be compressed.

Precautions: – Carefully tighten the screw with the compression sleeve.

Forceful tightening could cause stripping of the shaft thread.

– If the thread strips, some or all of the compression will be lost. If the screw is then countersunk correctly, the thread will regain purchase, thereby reducing the danger of post-operative screw loosening.

If an inadvertent event (e.g.: compression loss) makes screw removal necessary, follow the instructions on page 15.


7Countersink screw

Instruments

HCS 4.5


03.226.041 Screwdriver, cannulated, Stardrive T15

HCS 6.5


03.227.041 Screwdriver, cannulated, hexagonal

Remove the compression sleeve handle and slide the cannu-lated screwdriver through the compression sleeve and into the recess of the screw.

Countersink the screw by turning the screwdriver shaft clockwise, while simultaneously holding the compression sleeve stationary.

Verify the screw position with the image intensifier. Ensure that the screw head is properly countersunk: it should not project from the surface, while the screw tip should not penetrate the distal cortex. Remove and dispose of the guide wire.


Color markingsThe color markings on the screwdriver shaft indicate the position of the screwdriver tip and the head thread of the screw in the bone.

Green mark at the top end of the compression sleeveThe screw is fully threaded into the compression sleeve and the screwdriver tip is seated correctly in the recess of the screw.

Yellow mark at the top end of the compression sleeveThe top end of the head thread is even with the bone surface.

Note: If the screw is inserted at an angle, it must be countersunk further than the yellow mark so that it does not project from the surface.

Red mark at the top end of the compression sleeveThe top end of the head thread is approximately 2 mm below the bone surface.



Screw Extraction

Instruments

HCS 4.5


03.226.041 Screwdriver, cannulated, Stardrive T15

314.116 Screwdriver Shaft, Stardrive T15

311.440 T-Handle with Quick Coupling

HCS 6.5


03.227.041 Screwdriver, cannulated, hexagonal

313.930 Screwdriver, hexagonal, for Screw Removalor314.040 Screwdriver Shaft, hexagonal, for Screw Removal

Note: For removal of the HCS 4.5, use the Stardrive T15 screwdriver shaft with the T-Handle. For removal of HCS 6.5, use one of the screwdrivers for screw removal.

Note: If the screw strips, use the following procedure: Thread the compression sleeve over the screw head thread. Insert the cannulated screwdriver through the compression sleeve into the recess of the screw. Remove the screw by simultaneously pulling on the compres-sion sleeve and turning both the cannulated screwdriver and the compression sleeve in a counterclockwise direction.

Implant RemovalIn case the physician decides to remove the implants, im-plants can be removed by using general surgical instruments. In case of difficult removal circumstances, a Screw Extraction Set is available with corresponding instructions (036.000.917).

3.5 mm


Implants – HCS 4.5

HCS 4.5 – Headless Compression Screw, short thread

Art. No. Screw Shaft thread length (mm) length (mm)* L S

0X.226.620 20 7

0X.226.622 22 7

0X.226.624 24 7

0X.226.626 26 7

0X.226.628 28 7

0X.226.630 30 7

0X.226.632 32 7

0X.226.634 34 7

0X.226.636 36 7

0X.226.638 38 7

0X.226.640 40 8

0X.226.642 42 8

0X.226.644 44 9

0X.226.646 46 9

0X.226.648 48 9

0X.226.650 50 10

0X.226.652 52 10

0X.226.654 54 11

0X.226.656 56 11

0X.226.658 58 11

0X.226.660 60 12

0X.226.665 65 13

0X.226.670 70 14

0X.226.675 75 15

0X.226.680 80 16

* Shaft thread length is approximately 20% of the screw length.

X = 2: Stainless SteelX = 4: Titanium Alloy (TAN)All screws are also available sterile packed.

Only available sterile packed:Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.226.685S 85 17

0X.226.690S 90 18

0X.226.695S 95 19

0X.226.700S 100 20

0X.226.705S 105 21

0X.226.710S 110 22

L

S

3.5 mm



HCS 4.5 – Headless Compression Screw, long thread

Art. No. Screw Shaft thread length (mm) length (mm)* L S

0X.226.730 30 12

0X.226.732 32 12

0X.226.734 34 12

0X.226.736 36 14

0X.226.738 38 14

0X.226.740 40 16

0X.226.742 42 16

0X.226.744 44 18

0X.226.746 46 18

0X.226.748 48 18

0X.226.750 50 20

0X.226.752 52 20

0X.226.754 54 22

0X.226.756 56 22

0X.226.758 58 22

0X.226.760 60 24

0X.226.765 65 26

0X.226.770 70 28

0X.226.775 75 30

0X.226.780 80 32

* Shaft thread length is approximately 40% of the screw length.

X = 2: Stainless SteelX = 4: TANAll screws are also available sterile packed.


0X.226.785S 85 34

0X.226.790S 90 36

0X.226.795S 95 38

0X.226.800S 100 40

0X.226.805S 105 42

0X.226.810S 110 44

L

S


Instruments – HCS 4.5

Standard instruments

02.226. 000 Guide Wire B 1.6 mm with threaded tip with trocar, length 220 mm, Stainless Steel

312.770 �Protection Sleeve 9.5/7.0, for Percutaneous Insertion of Cannulated Screws B 4.5 mm

312.760 Drill Sleeve 7.0/3.2, for Percutaneous Insertion of Cannulated Screws B 4.5 mm

312.750 Drill Sleeve 3.2/1.6, for Percutaneous Insertion of Cannulated Screws B 4.5 mm

312.740 Trocar B 1.6 mm, for Percutaneous Insertion of Cannulated Screws B 4.5 mm

03.226.030 Direct Measuring Device for HCS – Headless Compression Screw B 4.5 mm

03.226.039 Drill Bit B 3.2/1.7 mm, cannulated, length 225 mm, 4 flute, for Quick Coupling


03.226.033 Compression Sleeve for HCS – Headless Compression Screw B 4.5 mm

03.226.037 Handle for Compression Sleeve for HCS – Headless Compression Screw B 4.5 mm

03.226.038 Attachment for Compression Sleeve for HCS – Headless Compression Screw B 4.5 mm

03.226.041 Screwdriver, cannulated, Stardrive, T15, for HCS – Headless Compression Screw B 4.5 mm


319.350 Cleaning Stylet B 1.6 mm, for Cannulated Instruments

03.226.042 Drill Bit for predrilling for screw head, cannulated, for HCS – Headless Compres-sion Screw B 4.5 mm




02.226. 001 Guide Wire B 1.6 mm with trocar tip, length 220 mm, Stainless Steel

03.226.040 Tap, cannulated, length 225 mm, for HCS – Headless Compression Screw B 4.5 mm

311.440 T-Handle with Quick Coupling

319.260 Cleaning Brush B 1.75 mm, for Cannulated Instruments

314.116 Screwdriver Shaft Stardrive 3.5, T15, self- holding, for AO/ASIF Quick Coupling


4.5 mm



HCS 6.5 – Headless Compression Screw, short thread

Art. No. Screw Shaft thread length (mm) length (mm) L S

0X.227.030 30 16

0X.227.035 35 16

0X.227.040 40 16

0X.227.045 45 16

0X.227.050 50 16

0X.227.055 55 16

0X.227.060 60 16

0X.227.065 65 16

0X.227.070 70 16

0X.227.075 75 16

0X.227.080 80 16

0X.227.085 85 16

0X.227.090 90 16

0X.227.095 95 16

0X.227.100 100 16

0X.227.105 105 16

0X.227.110 110 16

0X.227.115 115 16

0X.227.120 120 16



0X.227.125S 125 16

0X.227.130S 130 16

L

S

4.5 mm


HCS 6.5 – Headless Compression Screw, long thread

Art. No. Screw length Shaft thread length (mm) length (mm) L S

0X.227.245 45 32

0X.227.250 50 32

0X.227.255 55 32

0X.227.260 60 32

0X.227.265 65 32

0X.227.270 70 32

0X.227.275 75 32

0X.227.280 80 32

0X.227.285 85 32

0X.227.290 90 32

0X.227.295 95 32

0X.227.300 100 32

0X.227.305 105 32

0X.227.310 110 32

0X.227.315 115 32

0X.227.320 120 32



0X.227.325S 125 32

0X.227.330S 130 32

L

S




Standard instruments

292.680 Guide Wire B 2.8 mm with threaded tip with trocar, length 300 mm, Stainless Steel


312.080 Drill Sleeve 8.5/2.8

312.090 Drill Sleeve 15.5/13.0

312.020 Trocar B 2.8 mm

03.227.030 Direct Measuring Device for HCS – Headless Compression Screw B 6.5 mm

310.630 Drill Bit B 5.0 mm, cannulated, length 300/250 mm, 3-flute, for Quick Coupling



03.227.033 Compression Sleeve for HCS – Headless Compression Screw B 6.5 mm

319.460 Cleaning Stylet B 2.8 mm, for Cannulated Instruments

03.227.037 Handle for Compression Sleeve for HCS – Headless Compression Screw B 6.5 mm

03.227.038 Attachment for Compression Sleeve for HCS – Headless Compression Screw B 6.5 mm

03.227.041 Screwdriver, hexagonal, cannulated, for HCS – Headless Compression Screw B 6.5 mm


03.227.042 Drill Bit for predrilling for screw head, cannulated, for HCS – Headless Compression Screw B 6.5 mm

03.227.034 Sleeve vor Compression Sleeve for HCS – Headless Compression Screw B 6.5 mm



311.689 Tap, cannulated, for Cannulated Screws B 6.5 and 7.3 mm

02.227.001 Guide Wire B 2.8 mm with trocar tip, length 300 mm, Stainless Steel

03.111.002 Drill Bit B 5.0 mm, cannulated, calibrated, length 300/250 mm, 3-flute, for Quick Coupling

319.240 Cleaning Brush B 2.9 mm, for Cannulated Instruments

314.040 Screwdriver Shaft, hexagonal, for Screw Removal

313.930 Screwdriver, hexagonal, for Cannulated Screws B 6.5 and 7.3 mm, for Screw Removal


MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and for 15 minutes [3 T]).

Precautions: The above mentioned test relies on non-clini-cal testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning proce-dures.

– Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

0123

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.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 ©

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