SHARP HOOK

Description of Event or Problem

IT WAS REPORTED A SHARP HOOK WAS DISCOVERED BROKEN IN THE SET. THE SHARP HOOK IS BROKEN AT THE TIP. IT IS UNKNOWN AS TO HOW THE HOOK BROKE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET # (B)(4), REVISION. THERE WERE NO COMPLAINT-RELATED ANOMALIES, MRRS, OR NCRS ASSOCIATED WITH THIS LOT. A MANUFACTURING EVALUATION WAS COMPLETED; (B)(4) MANUFACTURED THE SHARP HOOK, P/N 319.39, LOT NUMBER 4078042 (SUPPLIER LOT # A7JA07). THE LOT INITIALLY WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET NUMBER (B)(4), REVISION. DUE TO AN UNKNOWN CAUSE, THE SHARP HOOK IS BROKEN AT THE TIP. THE PART EXHIBITS MINOR SCRATCHES AND NICKS. THE LOT WAS MANUFACTURED PER PO # (B)(4), DATED FEBRUARY 25, 2000, LINE # 4, FOR (B)(4) PARTS. THE ROUTER INDICATED ON MARCH 02, 2000. THE SHARP HOOK WAS MANUFACTURED TO THE SYNTHES SOURCE CONTROL DRAWING, P/N 319.39, REVISION "J", RELEASED ON OCTOBER 05, 2004. BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.