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CFN

CFN
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CFN

Product catalog summary
Introduction
The CFN - Cannulated Femur Nail is designed for treating femur fractures, providing stable fixation and allowing early weight bearing. Made from TiAl6V4 ELI material, it offers enhanced fatigue strength and reduces risks of cold welding and inflammation.
Indications & Contraindications
Indications include various femur fractures such as metaphyseal, diaphyseal, subtrochanteric, and supracondylar fractures. Contraindications include active infection, severe osteoporosis, and non-compliance from patients.
Surgical Technique
Pre-operative planning involves positioning the patient supine on a radiolucent table. The procedure includes making an incision near the greater trochanter, assembling the insertion guide, locating the entry portal, and performing nailing and locking procedures with fluoroscopic verification.
Postoperative Treatment
Standard protocols apply, with weight bearing and range of motion determined by the surgeon. The implant design facilitates easy nail removal.
Information on Dotize®
Dotize® is a surface treatment that enhances titanium implant properties, reducing inflammation risk and improving wear resistance through anodization.
Order List
The document includes a detailed order list for various sizes of cannulated femur nails, cortical screws, and associated surgical tools.
Product List
Includes components and tools such as trocars, impactor screws, socket wrenches, extraction rods, and endcaps, along with spare parts and optional instruments.
Specifications
Cannulated femur nails are available in diameters of 9mm, 11mm, and 13mm, and lengths from 300mm to 480mm, for both right and left orientations. Special sizes and instruments are available upon request.
Reconditioning Manual
Provides instructions for reconditioning non-sterile implants and reusable instruments, emphasizing product application, combinability, and handling.
Warnings and Preventive Measures
Implants should be used only once, without alterations, and regular follow-ups are essential. Combining implants from different producers is discouraged.
Cleaning and Sterilization Procedures
Details automatic and manual cleaning/disinfection processes, recommending specific cleaning agents and equipment, and guidelines for steam sterilization.
Maintenance and Inspection
Instruments should be inspected for cleanliness and functionality, with lubrication of movable parts and checks for ease of assembly.
Packaging and Sterilization
Hospitals are responsible for packaging and sterilizing instruments, with recommendations for steam sterilization using the fractionated pre-vacuum procedure.
Disposal and Recycling of Instruments
Outlines procedures for disposing of surgical instruments, especially when contamination with CJD pathogens is suspected, following hospital guidelines.
Responsibility for Lent Instruments
Emphasizes proper use and care of instruments to ensure longevity, with requirements for cleaning, disinfecting, inspecting, and sterilizing returned products.
Important Information
Reconditioners must validate and routinely inspect the reconditioning process, evaluating deviations for efficiency and potential negative impacts.
Patient Information
Patients should be informed about post-implantation behavior and the importance of reporting any negative changes or incidents.
Symbols and Standards
Lists symbols used on medical devices and compliance with standards like RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664.
Contact Information
Contact details for I.T.S. USA are provided for further inquiries.
See more

Catalog excerpts

CFN-1

Implants trauma Cannulated Femur Nail

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CFN-2

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, implant might break.

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CFN-3

1. Introduction P. 5 Preface P. 6 Screws P. 6 Properties P. 7 Pre-operative measurement of nail Length P. 8 Indications & Contraindications 2. Surgical Technique P. 10 Pre-operative patient planning P. 10 Incision P. 11 Assembly of the insertion guide P. 12 Locating entry portal P. 12 Nailing P. 13 Proximal Locking / Femoral Neck P. 14 Proximal Locking / Greater to lesser trochanter P. 15 Measuring of proximal screw length P. 16 Distal Locking P. 17 Measuring of distal screw length P. 18 Removal of the insertion guide P. 18 Endcap insertion P. 20 Postoperative treatment P. 20 Na il removal 3....

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CFN-5

Preface The newly developed CFN - Cannulated Femur Nail enables the surgical treatment of various fractures of the femur. Stable, ridged fixation of fractures can be achieved, with the advantage of early weight bearing due to intramedullary insertion.

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CFN-6

32652-xxx Cortical Screw, D=6.5mm 61502-350 Spiral Drill, D=5.0mm, L=350mm, AO Connector 54353-230SH Screwdriver Shank, PRS, Solid, WS 3.5mm, L=230mm, AO Connector 32475-xx Cortical Screw, D=4.7mm 61427-140 Spiral Drill, Angledrived, D=4.2mm, L=140mm 54353-230SH Screwdriver Shank, PRS, Solid, WS 3.5mm, L=230mm, AO Connector o Properties Properties of the material: ♦ Nail material: TiAl6V4 ELI ♦ Material of screw: TiAl6V4 ELI ♦ Easier removal of the implant is necessary ♦ Improved fatigue strength of the implant ♦ Reduced risk of cold welding ♦ Reduced risk of inflammation and allergy Properties...

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CFN-7

Preoperative identification of nail length 1. Determine the nail length with the template (see right) and a X-Ray Attention: Scale 1.6:1 2. Determine the nail length with the X-Ray ruler (59203). 3. Insert the calibrated D=3.0mm guide wire with ball tip (35301-800) or the D=2.5mm guide wire (35251-800) and read off the required nail length at the calibrated guide wire. Scale 1.6:1

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CFN-8

Indications: ♦ Open and closed metaphyseal and diaphyseal fractures ♦ Subtrochanteric and supracondylar fractures ♦ Segmental fractures ♦ Non-unions, mal-unions and delayed union fractures ♦ Pathological fractures, impending pathological fractures and tumor resections ♦ Fractures proximal to a total knee arthroplasty Contraindications: ♦ Active infection ♦ Skeletally immature patients ♦ Severe osteoporosis or inadequate bone stock ♦ Skin and soft tissue problems ♦ Foreign body (material) sensitivity ♦ Obesity ♦ Lack of patient compliance

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CFN-9

Surgical Technique

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CFN-10

o Incision ♦ Incision 2 - 3cm proximal to the greater trochanter in line with the longitudinal axis of the femur. ♦ Longitudinally split the fascia and use a trochar or finger palpation to identify the greater trochanter.

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CFN-11

o Assembly of the insertion guide tm- Assembly the fastening nut (118006-4) with the flatwrench, WS 20 (70020) Assembly the fastening screw (118007-4) with the socket wrench, WS 10, L=250mm (561002-250) To attach the jig to the handle, rotate the spinning fastener clockwise. Turn it until it stops and move it into the provided slots (highlighted in yellow). Advice: To verify the correct assembly of the insertion guide, insert a tissue protection sleeve and a drill sleeve into a guide hole in the jig. Then push the drill through the drill sleeve in the appropriate nail interlock hole.

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CFN-12

• Identification of the insertion portal is extremely important. The drill tip, guide wire or awl should be inserted at the medial edge of the greater trochanter on the AP fluoroscopic view and in line with the longitudinal axis of the femur on the lateral fluoroscopic view. • Open the proximal medullary canal with the required drill, awl or gimlet to the desired diameter with the appropriate soft tissue protector in place. • Introduce the D=3.0mm guide wire with ball tip (35301-800) when using the optional available reamer down to the level of the fracture, reduce the fracture and pass the guide...

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CFN-13

Proximal Locking / Femoral neck • For the proximal Locking into the femoral neck the screw alignment guide is attached to the handle with the spinning fastener (see page 11). • Insert the trochar (118007-8) through the D=5.1mm drill sleeve (118007-7) and advance to the cortex through a stab incision. • Remove the trochar and insert the spiral drill, D=5.0mm, L=350mm, AO Connector (61502-350) to drill through the drill sleeve. • Measure the screw length. • Insert a D=6.5mm cortical screw (32652-XXX) of appropriate length determined previously through the tissue protection sleeve. • Verify the...

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CFN-14

Proximal Locking / Greater to lesser trochanter • For the proximal Locking into the lesser trochanter the tissue protection sleeve (118007-5) is inserted directly on the handle (118007-1) • Insert the trochar (118003-12) through the D=5.1mm drill sleeve (118007-7) and advance to the cortex through a skin incision. • Remove the trochar and insert the spiral drill, D=5.0mm, L=350mm, AO Connector (61502-350) to drill through the drill sleeve. • Measure the screw length. • Insert a D=6.5mm cortical screw (32652-XXX) of appropriate length determined previously through the tissue protection sleeve....

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CFN-15

Measuring of proximal screw length Drill the screw holes under fluoroscopy, then read off the required screw length at the end of the calibrated D=5.0mm spiral drill (61502-350).

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CFN-16

Distal Locking • Distal locking is carried out using fluoroscopy and perfect circle technique. • Before locking, the correct reduction should be verified. • The spiral drill, angledrived, D=4.2mm, L=140mm (61427140) is used to drill through the medial and lateral cortex. Measure the screw length. Insert a D=4.7mm cortical screw (32475-XX) of appropriate length determined previously. • Additionally the screw should rise above the lateral cortex at least 2mm • Verify the correct screw position in the fluoroscopy. Attention: Do not overtighten the scre

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.