COUNTERSINK FOR 3.5MM CORTEX AND 4.0MM CANC BONE SCREWS

Additional Manufacturer Narrative

THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER A PERIOD OF 6 MONTHS, IT APPEARED THAT RUST WAS PRESENT ON THE SURFACE OF BOTH NEW AND OLD INSTRUMENTATION IN THE HOSPITAL INVENTORY. THE FACILITY REPORTED THAT PART # 399.410 (HAMMER) EXHIBITED FEATURES THAT MAY INDICATE RETENTION OF CONTAMINANTS IN THE METAL OF THE INSTRUMENT CAUSING LEAKAGE FROM THE MOLECULAR FISSURES DURING THE WASHING AND STERILIZATION PROCESS. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PERFORMED INVESTIGATION HAS CONFIRMED THAT RESIDUES AND STAINS ARE VISIBLE ON THE INSTRUMENTS. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE DRILL BIT, COUNTERSINK AND EXTRACTION SCREW WERE MANUFACTURED IN 2012 ACCORDING TO THE SPECIFICATIONS. SINCE THE HAMMER DOES NOT HAVE A LOT NUMBER, IT IS NOT POSSIBLE TO DEFINE THE PRODUCTION PERIOD, AND TO VERIFY THE MANUFACTURE DOCUMENTS. HOWEVER, THE MISSING LOT NUMBER IS AN INDICATION THAT THIS ITEM IS MORE THAN 10 YEARS OLD. UNFORTUNATELY THE EXACT CAUSE OF THE DAMAGE CANNOT BE DETERMINED, THE RESIDUES COULD BE REMOVED PARTLY. ACCORDING TO THESE FINDINGS, IT IS INDICATIVE THAT THE DEPOSITS ARE CAUSED BY RESIDUES AFTER CLEANING AND STERILIZATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.