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Medical Products Manufacturing and Trading Ltd.

1.1

FEMORAL NAILING WITH „Z“ TROCHANTERIC AND„Z“ LIGHT TROCHANTERIC NAIL

IMPLANTS AND OPERATING MANUAL

3

General informations

Before starting use the product

Before each use, carefully check the operability of implants and surgical instruments, and ensure they are free of any damage. If you notice any cracks, fractures, deformations, discoloration or any damages that indicate improper storage, imperfect sterilization or prior incorrect treatment, do not use the device. Always carry out the assembly, fitting and operation test of the implants and instruments to be used for the implantation. The product may only be used if the fittings are perfect, the dimensions are accurate, the clamping components work properly and the angles are correctly set.

Requirements regarding the user

The instruments and implants may only be used by qualified surgeons who are familiar with the surgical practice, with the relevant medical literature and are sufficiently experienced in the use of implants and instruments. The operating surgeon is responsible for identifying the correct indication, selecting the implants and conducting the surgical procedure in conformity with the relevant medical practice.

Contraindications

Use of the implant is not recommended if the medical condition of the patient does not allow successful acceptance of the device, or if the recovery of the patient is hindered by causes such as reduced blood circulation, bone system of poor quality or quantity, existing infection, rehabilitation excluded due to the mental condition of the patient etc.

General warnings

Before the surgical procedure, the patient should be informed about the possible disadvantages of implant use. When selecting the implant, the type of the bone fracture as well as the weight and activity level of the patient should always be taken into consideration. Since the solidity of the implant is limited, overloading due to overweight should be avoided. The biomechanical loading of the implant should be as minimal as possible. The process of recovery should be monitored during the use of the implant. In the event of repeated loading or prolonged bone recovery, the implants may be deformed or dislocated, which should be prevented by timely interventions. Strong and/or repeated deformation of the implant should be avoided. The implants are only for single use, re-implantation is prohibited. The appropriate type and correct size of the implants must be identified according to the characteristics of the particular case. Before the surgical procedure, the user manuals supplied with the other required devices, e.g. implants, should be carefully studied.

Applied materials

The applied materials are high-quality and high-tensile, nonmagnetic, stainless steel and titanium alloy materials specially developed for implants. Combined use with other materials or products supplied by other manufacturers may lead to harmful processes for which Medimetal Ltd. will not accept any responsibility.

Protection, packaging and preparation for use

The implants are packaged in clean condition, free of any production-related contaminations. Before use, such storage conditions must be ensured that will preserve the integrity of the packaging. The implants should be stored in a clean, dry place, protected from exposure to extreme temperatures and chemicals.

Sterilization

Before use, unpack and sterilize the implant in accordance with the relevant instructions. Do not touch the implant with bare hands. The surgical instruments should be sterilized together with the instrument tray. The instructions provided by the manufacturer of the sterilization equipment must always be followed.

Interactions with medicinal products

It is not known whether the implants interact with medicinal products.

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ISO 9001EN ISO 13485

ID 0: 79 81 60 65 0

1008

4

System of implants:

solid or cannulated, diameter 11 -12 mm, with CCD angle 130° or 135°, length from 180 to 240 mm, steel or titanium alloyDynamic screw:Thread diameter 12,6 mm, core diameter 8,0 mm, pitch 3,0 mm, steel or titanium alloyFixing screw: steel (cat. nr. 12401-09020) or titanium alloy (32401-09020)Locking screw: diameter 4,9 mm, steel or titanium alloyEnd cup: steel (cat. nr. 12400-14022) or titanium alloy (cat. nr. 32400-14022)

1.1

Implants for „Z“-type trochanteric nailing

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„Z“-type trochanteric nail, short:

„Z“-type trochanteric nail, long left, right:

solid or cannulated, diameter 10 mm, with CCD angle 130° or 135°, left or right, length from 340 to 420 mm, steel or titanium alloyDynamic screw:Thread diameter 12,6 mm, core diameter 8,0 mm, pitch 3,0 mm, steel or titanium alloyFixing screw: steel (cat. nr. 12401-09020) or titanium alloy (32401-09020)Locking screw: diameter 4,9 mm, steel or titanium alloyEnd cup: steel (cat.nr. 12400-14022) or titanium alloy (cat. nr. 32400-14022)

„Z“-type trochanteric nail, light, short:

proximal diameter 15,5 mm, cannulated, distal diameter 9 -11 mm, with CCD angle 125°, 130° or 135°, length from 180 to 240 mm, steel or titanium alloyDynamic screw:Thread diameter 10,5 mm, core diameter 7 mm, pitch 3 mm, steel or titanium alloyFixing screw: steel (cat. nr. 12401-08025) or titanium alloy (cat. nr. 32401-08025)Locking screw: diameter 4,9 mm, steel or titanium alloyEnd cup: steel (cat. nr. 12400-15022) or titanium alloy (cat. nr. 32400-15022)

„Z“-type trochanteric nail, light, long:

proximal diameter 15,5 mm, cannulated, distal diameter 9 -10 mm, with CCD angle 125°, 130° or 135°, length from 340 to 420 mm, steel or titanium alloyDynamic screw:Thread diameter 10,5 mm, core diameter 7 mm, pitch 3 mm, steel or titanium alloyFixing screw: steel (cat. nr. 12401-08025) or titanium alloy (cat. nr. 32401-08025)Locking screw: diameter 4,9 mm, steel or titanium alloyEnd cup: steel (cat. nr. 12400-15022) or titanium alloy (cat. nr. 32400-15022)

Grooved desidn at the 240 mm long nail for the prevention of cortical bone erosion

Aiming assistance for increased implantation accuracy

Plate box and dismountable part for easy cleaning

1008

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„Z“-type trochanteric nail, short

L(mm)

Catalogue number

steel

180200220240180200220240180200220240180200220240

14510-1118014510-1120014510-1122014510-1124014530-1118014530-1120014530-1122014530-1124014510-1218014510-1220014510-1222014510-1224014530-1218014530-1220014530-1222014530-12240

14500-1118014500-1120014500-1122014500-1124014520-1118014520-1120014520-1122014520-1124014500-1218014500-1220014500-1222014500-1224014520-1218014520-1220014520-1222014520-12240

titanium alloy steel titanium alloy(mm)

11111111111111111212121212121212

(°)

130130130130135135135135130130130130135135135135

cannulated solid

34510-1118034510-1120034510-1122034510-1124034530-1118034530-1120034530-1122034530-1124034510-1218034510-1220034510-1222034510-1224034530-1218034530-1220034530-1222034530-12240

34500-1118034500-1120034500-1122034500-1124034520-1118034520-1120034520-1122034520-1124034500-1218034500-1220034500-1222034500-1224034520-1218034520-1220034520-1222034520-12240

„Z“-type trochanteric nail, long, right or left

L(mm)

Catalogue number

steel

340360380400420340360380400420

14610-3413014610-3613014610-3813014610-4013014610-4213014610-3413514610-3613514610-3813514610-4013514610-42135

14630-3413014630-3613014630-3813014630-4013014630-4213014630-3413514630-3613514630-3813514630-4013514630-42135


10101010101010101010

(°)

130130130130130135135135135135

long, right, cannulated long, right, solid

34610-3413034610-3613034610-3813034610-4013034610-4213034610-3413534610-3613534610-3813534610-4013534610-42135

34630-3413034630-3613034630-3813034630-4013034630-4213034630-3413534630-3613534630-3813534630-4013534630-42135

L(mm)

Catalogue number

steel

340360380400420340360380400420

14600-3413014600-3613014600-3813014600-4013014600-4213014600-3413514600-3613514600-3813514600-4013514600-42135

14620-3413014620-3613014620-3813014620-4013014620-4213014620-3413514620-3613514620-3813514620-4013514620-42135


10101010101010101010

(°)

130130130130130135135135135135

long, left, cannulated long, left, solid

34600-3413034600-3613034600-3813034600-4013034600-4213034600-3413534600-3613534600-3813534600-4013534600-42135

34620-3413034620-3613034620-3813034620-4013034620-4213034620-3413534620-3613534620-3813534620-4013534620-42135

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L (mm)

Catalogue number

steel

12700-1207512700-1208012700-1208512700-1209012700-1209512700-1210012700-1210512700-12110

titanium alloy

Dynamic screw for short „Z“-type trochanteric nail

Thread diameter: 12,6 mmCore diameter: 8,0 mmPitch: 3,0 mm

7580859095

100105110

32700-1207532700-1208032700-1208532700-1209032700-1209532700-1210032700-1210532700-12110

12700-1211512700-1212012700-1212512700-1213012700-1213512700-1214012700-12145

32700-1211532700-1212032700-1212532700-1213032700-1213532700-1214032700-12145

L (mm) steel titanium alloy

115120125130135140145

Catalogue number

Fixing screw for short and long „Z“-type trochanteric nailCat. nr.

steel

12401-09020

titanium alloy

32401-09020

End cup screw for short and long „Z“-type trochanteric nail

Cat. nr.

steel

12400-14022

titanium alloy

32400-14022

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Locking screw for all type of „Z“ trochanteric nail

L(mm) steel titanium alloy

20222425262830323435363840

12200-4902012200-4902212200-4902412200-4902512200-4902612200-4902812200-4903012200-4903212200-4903412200-4903512200-4903612200-4903812200-49040

42444546485052545556586062

12200-4904212200-4904412200-4904512200-4904612200-4904812200-4905012200-4905212200-4905412200-4905512200-4905612200-4905812200-4906012200-49062

L(mm)

Cat. nr.

steel titanium alloy

Cat. nr.

Thread diameter: 4,9 mmCore diameter: 4,2 mmPitch: 2,75 mmHead diameter: 8,0 mmHex width: 3,5 mm

12200-4906412200-4906512200-4906612200-4906812200-4907012200-4907212200-4907512200-4907612200-4907812200-4908012200-4908512200-4909012200-49100


Cat. nr.

646566687072757678808590

100

32200-4902032200-4902232200-4902432200-4902532200-4902632200-4902832200-4903032200-4903232200-4903432200-4903532200-4903632200-4903832200-49040

32200-4904232200-4904432200-4904532200-4904632200-4904832200-4905032200-4905232200-4905432200-4905532200-4905632200-4905832200-4906032200-49062

32200-4906432200-4906532200-4906632200-4906832200-4907032200-4907232200-4907532200-4907632200-4907832200-4908032200-4908532200-4909032200-49100

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Surgical instruments for „Z“-type trochanteric nailing

Surgical set

Two trays for „Z“-type trochanteric nailing instrumet set,complete with instruments: cat. nr. 94500-00000

Cat. no. Description pcs

94500-00100 Proximal targeting arm, radiolucent 1

94500-00301 Aiming arm attachment, 135° 1

94500-00201 Aiming arm attechment, 130° 1

94500-00800 Compressing device 1

94500-00900 Hollow reamer 1

94500-01100 Slide hammer 1

94500-02501 Hammer guide head 1

94500-00600 T wrench 1

94500-01000 Hammer guide shaft 1

94500-00400 Aiming arm fixing screw 1

94500-00500 Nail adapter screw 1

94500-00700 Threaded stem for dynamic screw 1

94500-00203 Aiming arm clamp screw 2

15000-35400 Kirschner wire, 3,5 × 400 mm 1

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5.

6.

7.

8.

9.

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11.

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Tray I. for „Z“-type trochanteric nailing

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7

8

1 2 3 4 5

10 119 12 13 14

Cat. nr. 94500-10000

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99000-00006 Universal chuck with T handle 1

94500-01600 Drill guide for dynamic screw reamer, (red) 1

94500-01700 Gauge for dynamic screw 1

94500-01400 Reamer for dynamic screw, 12,8 mm 1

94500-02300 Cardan screw driver with quick coupling 1

94500-02400 Cardan rod for removal device 1

94500-02100 Hexagonal screwdriver, 3,5 mm 1

94500-01004 Fixation sleeve for removal device 1

94500-01200 Soft tissue protector for dynamic screw, (yellow) 1

94500-01300 Drill sleeve for guide wire, (yellow) 1

94500-01800 Soft tissue protector for locking screw, (green) 1

94500-01900 Drill sleeve for distal locking drill (green) 1

99010-40310 Spiral drill, 4 × 310 mm, (green) 1

94500-02200 Hexagonal screwdriver shaft, 10 mm 1

99000-00011 Wrench, 12 mm 1

94500-02600 Hexagonal screwdriver with quick coupling, 3,5 mm 1

94500-02000 Depth gauge for locking screw 1

99010-32350 Spiral drill, 3,2 × 350 mm, (yellow) 1

15020-30400 Threaded Kirschner guide wire, 3 × 400 mm 4

94500-01500 Reamer for dynamic screw, (red) 1

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

Pos.

Tray II. for „Z“-type trochanteric nailing

Cat. nr. 94500-20000

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Surgical instruments for „Z“-type trochanteric nailing

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28 29 30 31 32 33 34

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27

25

23

24

26

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„Z“-type trochanteric nail, light, short, cannulated, proximal diameter 15,5 mm

L(mm)

Catalogue number

steel

180200220240180200220240180200220240

14551-0918014551-0920014551-0922014551-0924014551-1018014551-1020014551-1022014551-1024014551-1118014551-1120014551-1122014551-11240

titanium alloy(mm)

9999

1010101011111111

125°

steel

14531-0918014531-0920014531-0922014531-0924014531-1018014531-1020014531-1022014531-1024014531-1118014531-1120014531-1122014531-11240

titanium alloysteel

14511-0918014511-0920014511-0922014511-0924014511-1018014511-1020014511-1022014511-1024014511-1118014511-1120014511-1122014511-11240

titanium alloy

130° 135°

34551-0918034551-0920034551-0922034551-0924034551-1018034551-1020034551-1022034551-1024034551-1118034551-1120034551-1122034551-11240

34511-0918034511-0920034511-0922034511-0924034511-1018034511-1020034511-1022034511-1024034511-1118034511-1120034511-1122034511-11240

34531-0918034531-0920034531-0922034531-0924034531-1018034531-1020034531-1022034531-1024034531-1118034531-1120034531-1122034531-11240

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Implants for „Z“-type light trochanteric nailing

„Z“-type trochanteric nail, light, long, cannulated, proximal diameter 15,5 mm

L(mm)

Catalogue number

steel

340360380400420340360380400420

14615-3412514615-3612514615-3812514615-4012514615-4212514614-3412514614-3612514614-3812514614-4012514614-42125

titanium alloy(mm)

99999

1010101010

=125°

steel

14615-3413514615-3613514615-3813514615-4013514615-4213514614-3413514614-3613514614-3813514614-4013514614-42135

titanium alloysteel

14615-3413014615-3613014615-3813014615-4013014615-4213014614-3413014614-3613014614-3813014614-4013014614-42130

titanium alloy

=130° =135°

L(mm)

Catalogue number

steel

340360380400420340360380400420

titanium alloy(mm)

99999

1010101010

steel titanium alloysteel titanium alloy

long, right

34615-3412534615-3612534615-3812534615-4012534615-4212534614-3412534614-3612534614-3812534614-4012534614-42125

34615-3413034615-3613034615-3813034615-4013034615-4213034614-3413034614-3613034614-3813034614-4013034614-42130

34615-3413534615-3613534615-3813534615-4013534615-4213534614-3413534614-3613534614-3813534614-4013534614-42135

=125° =130° =135°long, left

14605-3412514605-3612514605-3812514605-4012514605-4212514604-3412514604-3612514604-3812514604-4012514604-42125

14605-3413514605-3613514605-3813514605-4013514605-4213514604-3413514604-3613514604-3813514604-4013514604-42135

14605-3413014605-3613014605-3813014605-4013014605-4213014604-3413014604-3613014604-3813014604-4013014604-42130

34605-3412534605-3612534605-3812534605-4012534605-4212534604-3412534604-3612534604-3812534604-4012534604-42125

34605-3413034605-3613034605-3813034605-4013034605-4213034604-3413034604-3613034604-3813034604-4013034604-42130

34605-3413534605-3613534605-3813534605-4013534605-4213534604-3413534604-3613534604-3813534604-4013534604-42135

long, right long, right

long, left long, left

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Implants for „Z“-type light trochanteric nailing

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Locking screw for all type of „Z“ trochanteric nail


20222425262830323435363840

12200-4902012200-4902212200-4902412200-4902512200-4902612200-4902812200-4903012200-4903212200-4903412200-4903512200-4903612200-4903812200-49040

42444546485052545556586062

12200-4904212200-4904412200-4904512200-4904612200-4904812200-4905012200-4905212200-4905412200-4905512200-4905612200-4905812200-4906012200-49062

L(mm)

Cat. nr.

steel titanium alloy

Cat. nr.

Thread diameter: 4,9 mmCore diameter: 4,2 mmPitch: 2,75 mmHead diameter: 8,0 mmHex width: 3,5 mm

12200-4906412200-4906512200-4906612200-4906812200-4907012200-4907212200-4907512200-4907612200-4907812200-4908012200-4908512200-4909012200-49100


Cat. nr.

646566687072757678808590

100

32200-4902032200-4902232200-4902432200-4902532200-4902632200-4902832200-4903032200-4903232200-4903432200-4903532200-4903632200-4903832200-49040

32200-4904232200-4904432200-4904532200-4904632200-4904832200-4905032200-4905232200-4905432200-4905532200-4905632200-4905832200-4906032200-49062

32200-4906432200-4906532200-4906632200-4906832200-4907032200-4907232200-4907532200-4907632200-4907832200-4908032200-4908532200-4909032200-49100

Dynamic screw for light, short „Z“-type trochanteric nail

Thread diameter: 10,5 mmCore diameter: 7,0 mmPitch: 3,0 mm

L (mm)

Catalogue number

steel

12721-1107512721-1108012721-1108512721-1109012721-1109512721-1110012721-11105

titanium alloy

7580859095

100105

L (mm) steel titanium alloy

110115120125130135140

Catalogue number

Fixing screw for light, short „Z“-type trochanteric nail

Cat. nr.

steel

12401-08025

titanium alloy

32401-08025

End cup screw for light, short „Z“-type trochanteric nail

Cat. nr.

steel

12400-15022

titanium alloy

32400-15022

32721-1107532721-1108032721-1108532721-1109032721-1109532721-1110032721-11105

12721-1111012721-1111512721-1112012721-1112512721-1113012721-1113512721-11140

32721-1111032721-1111532721-1112032721-1112532721-1113032721-1113532721-11140

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Surgical instruments for „Z“-type light trochanteric nailing

Surgical set

Two trays for „Z“-type light trochanteric nailing instrumet set,complete with instruments: cat. nr. 94501-00000

Tray I. for „Z“-type light trochanteric nailing

Cat. nr. 94501-100001 2 3 4 5

11

12 14

6 7

8

9

10

13 15Cat. no. Description pcs

94501-00100 Targeting arm, radiolucent 1




94500-00400 Aiming arm fixing screw 1

94501-00500 Nail adapter screw 1

94500-00800 Compressing device 1

94500-01100 Slide hammer 1

94500-02501 Hammer guide head 1

94500-00600 T wrench 1

15000-35400 Kirschner wire, 3,5 × 400 mm 1

94500-01000 Hammer guide shaft 1

94500-00203 Aiming arm clamp screw 3

94650-00700 Threaded stem for dynamic screw 1

94501-00900 Hollow reamer 1

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

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Surgical instruments for „Z“-type light trochanteric nailing

Tray II. for „Z“-type light trochanteric nailing

Cat. nr. 94501-20000


99000-00006 Universal chuck with T handle, cannulated 1

94500-02600 Hexagonal screwdriver with quick coupling, 3,5 mm 1

94500-02200 Hexagonal spherical screwdriver shaft, 10 mm 1

94500-01700 Gauge for dynamic screw 1

94501-02300 Cardan screw driver with quick coupling, 3,5 mm 1

94501-02400 Cardan rod for removal device 1

94500-02100 Hexagonal screwdriver, 3,5 mm 1

94500-01004 Fixation sleeve for removal device 1

94501-01200 Soft tissue protector for dynamic screw, (yellow) 1

94501-01300 Drill sleeve for guide wire, (yellow) 1

94500-01800 Soft tissue protector for locking screw, (green) 1

94500-01900 Drill sleeve for locking drill (green) 1

99010-40310 Spiral drill, 4 × 310 mm, (green) 1

99000-00011 Wrench, 12 mm 1

15020-30400 Threaded Kirschner guide wire, 3 × 400 mm 4

94500-02000 Depth gauge for locking screw 1

99010-32350 Spiral drill, 3,2 × 350 mm, (yellow) 1

94501-01400 Reamer for dynamic screw, (yellow) 1

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

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29.

30.

31.

32.

33.

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16 17 18 19 20 21 22

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27

28

29 30 31 32 33

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Notes

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Notes

3304 Eger, Berva-völgy, HungaryTel.: +36 36 415 577Fax: +36 36 415 577/13E-mail: [email protected]

Medical Products Manufacturing and Trading Ltd.

Rev.: Z

TR

/A06-2016/K

I

AILING FEMUR

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