PERIOSTEAL ELEVATOR, STRAIGHT, 14MM WIDE
Received Jun 24, 2013
Report 8030965-2013-03688 · MDR key 3185104
Device
Product problems
- Corroded
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, IT WAS NOTED THAT THE SURFACE OF THE 14MM PERIOSTEAL ELEVATOR WAS RUSTY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Additional Manufacturer Narrative
(B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE CUTTING SURFACES OF THIS INSTRUMENT ARE BADLY DAMAGED (WEAR AND TEAR OVER THE YEARS), AND THE SURFACE SHOWS SLIGHT SIGNS OF RUST (SOLD MARCH 2009). THERE IS EVIDENCE THAT THESE DEPOSITS HAVE BUILT UP DUE TO RESIDUES FROM THE CLEANING AND STERILISATION PROCESS. ALL MATERIALS, EVEN SO-CALLED RUST-RESISTANT STEEL, ARE ONLY CORROSION FREE TO A LIMITED DEGREE. PLEASE NOTE THAT THESE ARTICLES REQUIRE ESPECIALLY CAREFUL TREATMENT. THE RUST-RESISTANT QUALITIES ONLY APPLY WHEN THE MATERIAL IS ALWAYS DRIED STRAIGHT AWAY AND STORED IN A DRY PLACE. WE DID NOT FIND THERE TO BE ANY FAULT IN THE PRODUCT.