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FTN

FTN
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FTN

Product catalog summary
Introduction
The document provides detailed information about the FTN Flexible Titanium Nail, a medical device used for bone stabilization in fracture treatment. It highlights the features, indications, contraindications, surgical techniques, and guidelines for handling and sterilization.

Features
The implant is made from Titanium alloy TiAl6V4 ELI, available in diameters ranging from 2.0 mm to 4.5 mm, and a length of 400 mm. The nail can be cut intraoperatively and has a curved tip for easy insertion and fracture repositioning.

Indications and Contraindications
The nail is suitable for fractures in children and adolescents with open epiphyseal plates, certain osteoporotic fractures, and specific types of fractures such as lower leg shaft, femoral shaft, and supracondylar humeral fractures. It is contraindicated in fragmented fractures and those with larger bone wedges.

Surgical Techniques
Various surgical techniques are outlined for different fracture types, including forearm, humerus, femur, and metacarpal/metatarsal fractures. Techniques emphasize minimally invasive procedures, functional therapy, and specific insertion methods.

Material and Anodization
The document discusses the anodization process, including Type II and Type III anodization, which enhances the implant's surface properties, reducing inflammation risk and improving wear resistance.

Handling and Sterilization Guidelines
Instructions for sterilization and reconditioning of the implants and instruments are provided, emphasizing the use of steam sterilization and careful handling to avoid damage. The document also outlines the responsibilities of medical staff in maintaining and inspecting the instruments.

Patient and Hospital Responsibilities
Patients should be informed about post-implantation care, and hospitals are responsible for the proper handling and sterilization of instruments. The document stresses the importance of following validated procedures for reconditioning medical products.

Conclusion
The FTN Flexible Titanium Nail offers a versatile and minimally invasive solution for fracture treatment, with detailed guidelines ensuring its effective and safe use in medical settings.
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Catalog excerpts

FTN-1

FTN FLEXIBLE TITANIUM NAIL emergency team for broken bones®

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FTN-2

Preface Summary When used in appropriate indications, flexible titanium nails offer the possibility for early functional treatment including minimally invasive fracture reposition, retention with elastical stable medullary nailing allowing for undisturbed periosteal bone healing. This technique is particularly suitable for children and adolescents when epiphyseal plates are still open, and partially in patients with osteoporotic fractures (shoulder). Benefits are the minimally invasive surgical technique avoiding open reposition and soft tissue irritation, and the chance for undisturbed periosteal...

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FTN-3

can be shortened individually in a flexible way intraoperative cutting of the nail is possible FLEXIBLE TITANIUM NAIL i.t.s. 03

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FTN-4

Surgical Technique - Forearm fracture • adial insertion distally at the styloid process – ulnar insertion (sparing R soft tissue) from proximal at the olecranon. • ail thickness approx. 1/3 to 1/2 of the minimum medullary diameter. N • ails should be inserted into the opposite corticalis (radial head or distal N ulna, respectively), otherwise there is a risk of delayed fracture healing. • o cast required for immobilisation N • unctional therapy, allows for exercise until pain indicates exact F reposition FLEXIBLE TITANIUM NAIL emergency team for broken bones® 04 i.t.s.

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FTN-5

Surgical Technique - Humerus, subcapital • nsertion of nails - 3 nails after anterolateral incision slightly distal of the deltoid muscle attachment I • rilling with awl D • eposition closed R • pread open nails 2.5 - 3 mm in the humeral head S • ossibly percutaneous reposition of dislocated tuberosities, and fixation P with cannulated screws • mmobilisation with Resch’s bandage for 3 weeks I Surgical Technique Shaft fracture (femur, lower leg, humerus) • nsertion via 2 opposing incisions I (med. and lat.) • rilling – dilate with awl – nail D thickness approx. 1/3 of the minimum medullary diameter...

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FTN-6

Surgical Technique - Supracondylar humeral fracture in children • losed reposition C • nsertion of 2 nails from proximal I • ast for 3 week rest C FLEXIBLE TITANIUM NAIL emergency team for broken bones® Surgical Technique - Metacarpal – metatarsal V: • ncision I • rilling D • epositioning with nails R Nail removal Early after bony consolidation 06 i.t.s.

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FTN-7

Case reports FLEXIBLE TITANIUM NAIL Implant Order No. 1 Titanium Nail, Flexible, D=2.0mm, L=400 mm 1920-400 2 Titanium Nail, Flexible, D=2.5mm, L=400 mm 1925-400 3 Titanium Nail, Flexible, D=3.0mm, L=400 mm 1930-400 4 Titanium Nail, Flexible, D=3.5mm, L=400 mm 1935-400 5 Titanium Nail, Flexible, D=4.0mm, L=400 mm 1940-400 6 Titanium Nail, Flexible, D=4.5mm, L=400 mm 1945-400 i.t.s. 07

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FTN-8

® DOTIZE Chemical process - anodization in a strong alkaline solution * Type III anodization Dotize Type II anodization Layer thickness 60-200nm Layer thickness 2000-10 000nm + Different colors + Film become an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration - No visible cosmetical effect Anodization Type II leads to following benefits * • • • • • • • • Oxygen and silicon absorbing conversion layer Decrease in protein adsorption Closing of micro pores and micro cracks Reduced risk of inflammation and allergy Hardened titanium surface Reduced...

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FTN-10

Sterilization Guidelines The following remarks should serve as a guideline in the sterilization of medical products. IMPORTANT INDICATIONS FOR DOCTORS AND OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments from I.T.S. GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the package label. Make sure that you are familiar with the possibilities of application, combinability and correct handling of the product....

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FTN-11

Sterilization Guidelines Disinfection Equipment: Commercially available disinfectants authorized for use with medical products e.g.. MEDICLEAN FORTE) can be used (but only according to the instructions of the disinfectant producer). In the case of automatic cleaning, a final rinse cycle at 90 °C for 5 minutes can be finally carried out to provide thermal disinfection. Drying Drying as part of the cleaning/ disinfection cycle should not exceed 110 °C. Checking, Maintenance and Inspection • Each instrument or implant is to be inspected carefully to make sure that all visible dirt has been removed....

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FTN-12

part of the MED-HOLD GROUP alterations, errors and misprints

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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.