INTRAMEDULLARY NAILING TIBIA AND FEMUR 1.3 TIBIAL AND FEMORAL NAILING FEMORAL NAILING WITH RETROGRADE INSERTION IMPLANTS AND OPERATING MANUAL

Transcription

1 1.3 TIBIA AND FEMORA NAIING FEMORA NAIING WITH RETROGRADE INSERTION IMPANTS AND OPERATING MANUA INTRAMEDUARY NAIING TIBIA AND FEMUR Medical Products Manufacturing and Trading td.

2

3 General informations 1.3 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. TIBIA AND FEMORA NAIING Applied materials The applied materials are high-quality and high-tensile, nonmagnetic, stainless 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 td. 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. I D : ISO 9001 EN ISO

4 1.3 TIBIA NAIING Implants for tibial nailing System of implants: Tibial nail, cannulated: Diameter: 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm enght: from 270 mm to 420 mm Material: stainless or titanium alloy Guidewire dimension: diameter 3,0 mm ocking holes: on the side of lateral as well sagittal direction. The proximal locking as dynamic possible. ocking screw: diameter 4,9 mm, length from 20 mm to 100 mm, or titanium alloy End cup: (cat. nr ) or titanium alloy (cat. nr ) Anatomical fit, which ensures geometry. For the locking of the proximal end you can choose either statical or dynamizing holes. Either the lateral or sagittal direction is possible for distal locking

5 Tibial nail, cannulated Diameter: Material: ocking screw: Cap screw: mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm or titanium alloy from to () from to (titanium alloy) (), (titanium alloy) Catalogue number Implants for tibial nailing 8 mm 9 mm 10 mm titanium alloy titanium alloy titanium alloy TIBIA NAIING Catalogue number 11 mm 12 mm 13 mm titanium alloy titanium alloy titanium alloy

6 1.3 Implants for tibial nailing TIBIA NAIING ocking screw Thread diameter: 4,9 mm Core diameter: 4,2 mm Pitch: 2,75 mm Head diameter: 8,0 mm Hex width: 3,5 mm titanium alloy titanium alloy titanium alloy End cup screw for tibial nail titanium alloy

7 Surgical instruments for tibial nailing 1.3 Surgical set Two trays for tibia-femur-retrograde femoral nailing instrument set, complete with instruments: cat. nr TIBIA NAIING Tray I. for tibia-femur-retrograde femoral nailing Pos Cat. no. Description pcs Awl ength gauge Spiral drill, 6,0 195 mm Spiral drill, 4,2 310 mm Femoral guide Tibial guide Screw, M Reamer, 14 mm Teflon tube Drill with T-handle, mm Drill with T-handle, mm Hammer shaft, cannulated Threaded removal shaft Threaded stem, cannulated Hexagonal distal guide, 10/4,8 mm Soft tissue protector, 10/8,1 mm Drill sleeve, 8/3,6 mm Drill sleeve, 8/4,4 mm Drill sleeve, 8/6,1 mm 1 7

8 1.3 Surgical instruments for tibial nailing TIBIA NAIING Tray II. for tibia-femur-retrograde femoral nailing Pos Cat. no. Description pcs Hammer Hook for tibial nail, 3 mm Screw, M Holder ring for hook Screw, M Holder Screw for sagittal arm, M Sagittal arm Proximal aiming arm Hook for femoral nail, 3,5 mm Screwdriver, 3,5 mm Threaded fixing sheet Screw, M Wrench, 17 mm Hammer shaft block Wrench, 11 mm Distal aiming arm Rail guiding shaft Nut, M Washer Rail holding sheet Holder for aiming arm, previously on the tray mounted 1 8

9 Implants for femoral nailing 1.3 System of implants: Femoral nail, cannulated: Diameter: 9 mm, 10 mm, 11 mm, 12 mm, 13 mm ength: from 300 mm to 480 mm Material: stainless or titanium alloy Guidewire dimension: diameter 3,0 mm ocking holes: on the side of lateral direction. Proximal locking with 6,5 mm as well 4,9 mm locking screws. Proximal dinamization. ocking screw: diameter 4,9 mm, length from 20 mm to 100 mm, or titanium alloy ocking screw: diameter 6,5 mm, length from 40 mm to 130 mm, or titanium FEMORA NAIING End cup: (cat. nr ) or titanium alloy (cat. nr ) The stem of the femoral nail is developed with anatomical bending. The proximal end of the femoral nail ensures statical or dynamical locking. For the statical locking, 6,5 mm locking bone screws can be chosen too

10 1.3 Implants for femoral nailing FEMORA NAIING Femoral nail, cannulated Diameter: 9 mm, 10 mm, 11 mm, 12 mm, 13 mm Material: or titanium alloy ocking screw: diameter 4,9 mm from to () from to (titanium alloy) diameter 6,5 mm from to () from to (titanium alloy) Cap screw: (), (titanium alloy) Catalogue number 9 mm 10 mm 11 mm titanium alloy titanium alloy titanium alloy Catalogue number 12 mm 13 mm titanium alloy titanium alloy End cup screw for femoral nail titanium alloy

11 Implants for femoral nailing 1.3 ocking screw Thread diameter: Core diameter: Pitch: Head diameter: Hex width: titanium alloy ,9 mm 4,2 mm 2,75 mm 8,0 mm 3,5 mm titanium alloy titanium alloy FEMORA NAIING ocking screw Thread diameter: Core diameter: Pitch: Head diameter: Hex width: 6,5 mm 4,4 mm 2,5 mm 8,0 mm 3,5 mm titanium alloy titanium alloy

12 1.3 Implants for femoral nailing with retrograde insertion RETROGRADE FEMORA NAIING System of implants: Retrograde femoral nail, cannulated: Diameter: 9 mm, 10 mm, 11 mm, 12 mm, 13 mm ength: 240 mm and 300 mm Material: stainless or titanium alloy Guidewire dimension: diameter 3,0 mm ocking holes: on the side of lateral direction. Distal locking with 6,5 mm as well 4,9 mm. Proximal locking with 4,9 mm locking screws ocking screw: diameter 4,9 mm, length from 20 mm to 100 mm, or titanium alloy ocking screw: diameter 6,5 mm, length from 40 mm to 130 mm, or titanium End cup: (cat. nr ) or titanium alloy (cat. nr ) The stem of the retrograde femoral nail is developed with anatomical bending. For the statical locking of the distal end, 6,5 mm locking bone screws can be chosen too

13 Implants for femoral nailing with retrograde insertion 1.3 Retrograde femoral nail, cannulated Diameter: 9 mm, 10 mm, 11 mm, 12 mm, 13 mm Material: or titanium alloy ocking screw: diameter 4,9 mm from to () from to (titanium alloy) diameter 6,5 mm from to () from to (titanium alloy) Cap screw: (), (titanium alloy) Catalogue number 9 mm 10 mm 11 mm titanium alloy titanium alloy titanium alloy Catalogue number 12 mm 13 mm titanium alloy titanium alloy RETROGRADE FEMORA NAIING ocking screw Thread diameter: Core diameter: Pitch: Head diameter: Hex width: titanium alloy ,9 mm 4,2 mm 2,75 mm 8,0 mm 3,5 mm titanium alloy titanium alloy

14 1.3 Implants for femoral nailing with retrograde insertion RETROGRADE FEMORA NAIING ocking screw Thread diameter: Core diameter: Pitch: Head diameter: Hex width: titanium alloy ,5 mm 4,4 mm 2,5 mm 8,0 mm 3,5 mm End cup screw for retrograde femoral nail titanium alloy titanium alloy

15

16 Rev.: TFRF/A /KI Medical Products Manufacturing and Trading td Eger, Berva-völgy, Hungary Tel.: Fax: /13