HCS 1.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...

HCS 1.5. 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 1.5 Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

MRI Information 17

HCS 1.5 2

Indications 4

Surgical Technique for HCS 1.5 5

Screw Extraction 11

Implant Removal 11

Implants HCS 1.5 12

Instruments HCS 1.5 13

Sets 15

Overview of Product Line HCS 16

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 1.5 Surgical Technique

HCS 1.5. The countersinkable compression screw.

Stardrive T4For optimal torque transmission

Cutting flutes on screw headFacilitate countersinking of the screw.

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

Available in steel and titaniumAll Headless Compression screws from Synthes are available both in stainless implant-grade steel and high-quality biocompatible titanium alloy (TAN).

B 2.2 mm head thread

B 1.2 mm core diameter

B 1.5 mm shaft thread

Self-drilling tipShorter surgery due to simplifi ed surgical technique.


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 achieved, 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.

Functional principle: lag screw technique with compression sleeve


Indications

– Fixation of intra- and extra-articular fractures and non-unions of small bones and small bone fragments

– Arthrodesis of small joints – Osteochondral fractures – Osteotomies – Avulsion fractures


Surgical Technique for HCS 1.5

1aPredrilling for screw

Instruments

310.110 Drill Bit B 1.1 mm, length 60/35 mm, 2-flute, for Quick Coupling

312.140 Double Drill Guide 1.5/1.1

After a stab incision, advance the drill guide through the soft tissues to the bone. Insert the drill bit through the drill guide to the bone and drill to the desired depth.

Verify drill depth using the image intensifier.

Notes – The HCS 1.5 is self-drilling and may be inserted without

predrilling. – Omitting the predrill step does not allow for accurate

length measurement and it may be more difficult to insert the screw in hard cortical bone.

Precaution: Avoid forcefully advancing or bending the drillbit as this may cause the drill bit to break.

1bPredrilling for head

Instruments

310.509 Drill Bit B 1.8 mm, length 110/85 mm, 2-flute, for Quick Coupling

323.202 Universal Drill Guide 2.4

It is recommended to predrill the near cortex with the drill bit to facilitate head insertion in dense bone and to prevent the bone from cracking.

Insert the drill bit in the drill guide and carefully predrill the cortex.



2Determine screw length

Instrument

319.003 Depth Gauge for Screws 1.3 to 1.5 mm, measuring range up to 24 mm

Measure the screw length using the depth gauge.

NoteConsider the following when selecting the screw length: – Account for fracture gap compression – Account for desired countersinking depth – Ensure the self-drilling screw tip will not penetrate the far

cortex

3Pick up screw

Instruments

03.230.003 Compression Sleeve for HCS – Headless Compression Screw B 1.5 mm

319.970 Screw Forceps, self-holding, length 85 mm

To remove a screw from the screw rack, twist the compres-sion sleeve over the head thread of the screw or use the screw forceps.


The position of the fracture line determines the screw length:

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

Incorrect screw length The shaft thread bridges the fracture gap or the osteotomy. Fragments cannot be compressed.



4Insert screw and compress fragment

Instruments

03.226.006 Handle for Compression Sleeve


Slide the handle into the compression sleeve. Insert the screw into the bone by turning the compression sleeve until the fracture gap or the osteotomy is closed and compressed.

Note: Verify the correct position of the shaft thread in the distal fragment using the image intensifier. If the thread bridges 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 loss of compression makes screw extraction necessary, follow the instructions on screw extraction on page 11.


5Countersink screw

Instruments

03.230.004 Screwdriver Shaft, Stardrive, T4, with colour marking, for HCS – Headless Compression Screw B 1.5 mm

311.430 Handle with Quick Coupling, length 110 mm


Remove the handle for compression sleeve from the com-pression sleeve. Assemble the screwdriver shaft to the handle with quick coupling and slide it through the compres-sion sleeve into the recess of the screw.

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

Note: Verify the screw position with the image intensi fier. Ensure that the screw tip does not penetrate the far cortex and that the screw head is properly countersunk.



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 flush with 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 flush with 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 flush with the top end of the compression sleeveThe top end of the head thread is approximately 1 mm below the bone surface.


Screw Extraction

Instruments


311.430 Handle with quick coupling, length 110 mm


309.200 Hollow Reamer, complete, anticlockwise cutting, for Screws B 2.0 mm

Note: For the extraction of the HCS 1.5 use the Screwdriver Shaft in combination with the handle with quick coupling.

Note: If the screw strips, use the following procedure: Thread the compression sleeve over the screw head thread. Insert the 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 screwdriver and the com-pression sleeve in counterclockwise direction.

Note: If necessary, expose the recess and part of the head thread with a hollow reamer (e.g. 309.200) or use another preferred method.

In case the physician decides to remove the implants, implants 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).

Implant Removal

L

S 1 mm


Implants HCS 1.5

HCS 1.5 – Headless Compression Screw, self-drilling

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

0X.230.108 8 4

0X.230.109 9 4

0X.230.110 10 4

0X.230.111 11 4

0X.230.112 12 4

0X.230.113 13 4

0X.230.114 14 4

0X.230.115 15 4

0X.230.116 16 5

0X.230.117 17 5

0X.230.118 18 5

0X.230.119 19 5

0X.230.120 20 6

X = 2: Stainless SteelX = 4: Titanium Alloy (TAN)

All implants are also available sterile packed. Add suffix “S” to article number.


Instruments HCS 1.5

03.230.003 Compression Sleeve for HCS – HeadlessCompression Screw B 1.5 mm


03.226.006 Handle for Compression Sleeve, for HCS – Headless Compression Screw

311.430 Handle with Quick Coupling, length 110 mm

319.970 Screw Forceps, self-holding, length 85 mm

312.140 Double Drill Guide 1.5/1.1

323.202 Universal Drill Guide 2.4

310.110 Drill Bit B 1.1 mm, length 60/35 mm, 2-fl ute, for Quick Coupling


Instruments HCS 1.5

319.003 Depth Gauge for Screws B 1.3 to 1.5 mm, measuring range up to 24 mm

310.509 Drill Bit B 1.8 mm, with marking, length 1110/85 mm, 2-fl ute, for Quick Coupling


Sets

01.230.002 Instrument and Implant Set for HCS – Headless Compression Screw B 1.5 mm (Stainless Steel) for Vario Case

01.230.004 Instrument and Implant Set for HCS – Headless Compression Screw B 1.5 mm (Titanium Alloy) for Vario Case


Overview of Product Line HCS

Thread B Material Thread length Screw length Guide wire B

1.5 mm Stainless Steel/TAN Variable (4–6 mm) 8–20 mm Not cannulated

2.4 mm Stainless Steel/TAN Short thread (variable) 9–20 mm 1.1 mm2.4 mm Stainless Steel/TAN Long thread (variable) 16–40 mm 1.1 mm





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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HCS 1.5. The countersinkable compression screw.synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...

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