Implants trauma PROlock Fibula Locking Plate

All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent several times. This is particularly important in the case of titanium implants, to prevent material fatigue and subsequent failure. The method of bending is the conscious responsibility of the operating doctor; I.T.S....

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Pre-operative patient preparation P. 10 Implantation P. 11 Postoperative treatment P. 11 Explantation P. 11 Case studies 3. Information P. 13 Locking P. 13 Dotize® P. 14 Order list P. 16 Reconditioning Manual P. 18 Notes

Preface The PROlock Fibula Locking Plate is a proven osteosynthesis system for various fractures of the distal fibula. The special feature of this implant is the free choice of screw placement. The user is able to set any desired screw in any hole either locking or non-locking screw (except oblong hole). The free choice of screw angulation (+/- 15°, see page 13) provides an advantage in fracture treatment, especially in the case of complex fractures.

Spiral Drill, D=2.0mm, L=100mm, AO Connector Self-holding sleeve, Screwdriver, Torque 9 Cancellous Screw, locking, D=3.0mm Spiral Drill, D=2.0mm, L=100mm, AO Connector Self-holding sleeve, Screwdriver, Torque 9

Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy Multi-directional Locking Anatomical plate design Ideal positioning due to oblong hole Left/right version Plate lengths: 4, 6, 8-hole

Indications, Contraindications & Time of operation Indications: • Dislocated ankle-fractures group B+C according to Weber (with or without comminuted zones) Existing infections in the fracture zone and operation area Common situations that do not allow osteosynthesis Obesity Lack of patient compliance Time of operation: • Immediately after injury • After regression of the swelling

Surgical Technique

Pre-operative patient preparation • Supine position • Primary Tourniquet • General or regional anesthesia Sterile washing and covering Typical distal fibula approach (lateral incision) Uncovering and cleaning of the fracture Open reduction and temporary fixation with clamps Temporary fixation with a lag screw possible Positioning of the anatomically formed fibula plate (left/right) to the reduced distal fibula and fixation with a D=2.7mm Cortical Screw through the oblong hole Fluoroscopic control of the reduction and plate position in a/p and lateral view Fill distal plate holes with D=3.0mm...

Postoperative treatment • Splinted shank for 2 weeks • Physical therapy • 6-8 weeks rest Explantation If desired by the patient, the implant can be removed. Removal should be performed at the earliest 1 1/2 years later or after radiographic verification of the healed bone. The problem of cold welding was resolved by using a special surface treatment (for further information see page 13). Case studies

Locking Locking works because: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Dotize Type II anodization • Layer thickness 2000-10 000nm + Film becomes an interstitial part of the titanium + Different colors - Implant surface remains sensitive to: Chipping Peeling Discoloration - No visible cosmetic effect Dotize® Type - II Anodization Type...

Order list Fibula Plate PROlock, 4-hole, Right 21221-4 Fibula Plate PROlock, 4-hole, Left 21222-4 Fibula Plate PROlock, 6-hole, Right 21221-6 Fibula Plate PROlock, 6-hole, Left 21222-6 Fibula Plate PROlock, 8-hole, Right 21221-8 Fibula Plate PROlock, 8-hole, Left 21222-8 Cancellous Screw, Locking, D=3.0mm, L=10mm Cancellous Screw, Locking, D=3.0mm, L=12mm Cancellous Screw, Locking, D=3.0mm, L=14mm Cancellous Screw, Locking, D=3.0mm, L=16mm Cancellous Screw, Locking, D=3.0mm, L=18mm Cancellous Screw, Locking, D=3.0mm, L=20mm Cortical Screw, D=2.7mm, L=10mm Cortical Screw, D=2.7mm, L=12mm Cortical...

Reconditioning Manual The information below should help you in reconditioning medical devices. IMPORTANT INDICATIONS FOR DOCTORS & OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied non-sterile 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 packaging label. Make sure that you are familiar with the possible application, combinability and correct handling of the product. Please note that product systems...

Manual disinfection If a cleaning agent without a disinfectant effect is used, separate disinfection must be carried out after manual cleaning. (Order: Decontamination for staff protection, cleaning, disinfection). Equipment: Commercially available disinfectant authorised for use with medical products from the VAH list. Manufacturer‘s information, e.g. concerning concentration, temperature and exposure time should be followed. The steps described in the table above also apply. Patient Information Implantation has consequences for the discomfort, mobility and general life circumstances of the...