Comptoir Hospitalier Orthopédique et Chirurgical

EASY-FIX system

Product description

Easy-screw and Easy-lig screws are manufactured at the facilities of SARL CHOC, rue Louis Lépine, Albasud 3, 82000 Montauban, France.

Easy-screw and Easy-lig screws are manufactured from PEEK OPTIMA LT1. All materials are obtained from ISO 9001 certified suppliers, who provide for each titanium delivery a material conformity certificate with a physicochemical analysis.

The screws are produced in accordance with our manufacturing procedures: a manufacturing order is issued by the Production Manager. For each manufacturing order, the Production Manager assigns a four digit batch number. The manufacturing order details all the operations to be carried out on the products. At each stage, various dimensional verifications are carried out by the manufacturing operators and by the Production Manager. All inspection forms are kept with the manufacturing order.

Dimensional characteristics

The Easy-screw has an 8 mm head diameter and a 4.4 mm screw body diameter and is available in the following lengths: 30-35-40 and 45mm.

The Easy-lig screw has an 8 mm diameter and length of 12 mm.

The EASY-FIX system is used in treating recent acromioclavicular separations with EASY-SCREW and old separations with EASY-LIG; this system is recognised for the easy, rapid and effective treatment of all types of acromioclavicular separations.

The system can be used with a minimally invasive technique that may possibly include an arthroscopic control, although this is not indispensable. The ancillary equipment is limited to a bone reduction forceps and a specific aiming device making the technique extremely simple.

The system has been designed to stay in place, thus requiring no secondary ablation. Furthermore, it prevents any use of additional stabilisation pins, which can lead to many complications.

To ensure traceability, the screws are individually packaged in double blister packs. The first contains the screw and a sterilisation indicator label. The second blister contains the first blister and five traceability stickers with the screw reference, description and batch number.

The packed screws are then sent to ISOTRON France (MIN des Arnavaux- 13014 MARSEILLE) for sterilisation by gamma radiation according to the ISO 11137-02, ISO 11737-1, ISO 11737-2, EN 552, EN 556 standards and dose mapping. After sterilisation, ISOTRON returns the batch of sterilised screws with a certificate of sterilisation by gamma radiation.

The screws in the packaging are then labelled. The label includes the description, the reference, the production batch number, the method of sterilisation, the expiry date, the "single use" and "read instructions before use" symbols, the manufacturer's name and address and the CE 1014 markings.

The screws are packed in boxes identically labelled as above, stretch-wrapped and stored in closed cupboards, away from direct light.

Storage conditions: no special conditions.

The biocompatibility analyses have been carried out by the raw material supplier: INVIBIO.

All results are kept by CHOC and may be made available to our customers.