Varisation staples
Product description
ISO 5832-1 standard stainless steel varisation staples
Varisation staples are used in osteotomy procedures without shortening.
After hallux valgus surgical procedures, there may still be a valgus, an external rotation or a lateral underlapping. This can be corrected by a first phalanx osteotomy. This osteotomy is set using a varisation staple.
Four types of staples are available. Each staple comes sterilised in a double blister pack with 5 traceability stickers.
The varisation staples are tooled from ISO 5832-1 standard 316L stainless steel. All materials are sourced from ISO 9000 certified suppliers. Each titanium delivery comes with a certificate of origin of the material.
The staples 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 varisation staples have a 10/10 cross-section, and are available in the following lengths: 90°-10mm centre distance / 90°-8mm centre distance / 26°-10mm centre distance / 26°-8mm centre distance.
VARISATION STAPLE
REF: 14.55.01 (90º - 10mm) - 14.55.02 (90º - 8mm)
14.55.03 (26º - 10mm) - 14.55.04 (26º - 8mm)
SURGICAL TECHNIQUE
The varisation staples are manufactured from ISO 5832-1 standard 316L stainless steel They are used in osteotomies without shortening.
On opening the peel-off blister, put to one side the traceability stickers (1 for order renewal, 4 for the patient file)
* Fixing the staple:
* Make a single distal pilot hole in the distal fragment, angled forwards and outwards
* Insert the staple using the corresponding staple holder (90 or 26º)
* Complete insertion using the corresponding staple punch. (90 or 26º)
To ensure traceability, the staples are individually packaged in double blister packs. The first contains the staple and a sterilisation indicator label. The second blister contains the first blister and five stickers with the staple reference, description and batch number.
The packed staples are then sent to ISOTRON FRANCE SA 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 products with a certificate of sterilisation by gamma radiation.
The staples in the packaging are then labelled. The label includes the description, the reference, the production batch number, the method of sterilisation, the sterilisation batch number, expiry date, the manufacturer's name and the CE 0499 markings.
The staples are packed in boxes identically labelled as above, and stored in closed cupboards, away from direct light.