SHARP HOOK

Additional Manufacturer Narrative

THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UPON RETURN OF LOAN KITS IT HAS BEEN FOUND DURING THE INSPECTION THAT THE SHARP HOOK L155 INSTRUMENT¿S TIP HAS BROKEN OFF AND IS MISSING. UNSURE IF THIS HAPPENED INTRAOPERATIVELY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 319.390 , SYNTHES LOT NUMBER: 9143710 , RELEASE TO WAREHOUSE DATE: 30.SEP.2014 , MANUFACTURING SITE: BETTLACH . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: INVESTIGATION SITE: ZUCHWIL , SELECTED FLOW: 5 BROKEN , VISUAL INSPECTION : THE VISUAL INSPECTION HAS SHOWN THAT THE TIP OF THE SHARP HOOK HAS BROKEN OFF. THE BROKEN OFF FRAGMENT WAS NOT RETURNED FOR EVALUATION. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-17584 PER DRAWING: OUTER SHAFT DIAMETER , SPECIFICATION 1.85MM +/-0.2 MM/ MEASURED: 1.99 MM = PASS . DOCUMENT/SPECIFICATION REVIEW: THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THIS SHARP HOOK WAS MANUFACTURED IN SEPTEMBER 2014 ACCORDING TO THE SPECIFICATIONS. MATERIAL/HARDNESS REVIEW : THE COMPONENT 1120 IS EXISTING OF TWO MATERIALS (1.4112 (HOOK) AND 1.4305 (HANDLE). THE DRAWING SHOES ONLY ONE MATERIAL. IN CONTEXT OF DCR 100190 THE MISSING MATERIAL 1.4305 WILL BE ADDED. TO THE DRAWING. THE LOTS OF THE RAW MATERIAL OF THE COMPONENTS OF THE HANDLE AND THE SHARP HOOK ARE NOT TRACKED BY NUMBER. SHARP HOOK IS HARDENED AND TEMPERED HRC 56 +/- 2.5 ACCORDING TO SE_124039 / DRAWING. SUMMARY: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS CONFIRMED. THE TIP OF THE SHARP HOOK IS BROKEN OFF AS COMPLAINED. DEVICE HISTORY REVIEW WAS PERFORMED FOR THE AFFECTED LOT, OF THE END PRODUCT AND ALSO FOR ITS COMPONENT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE TIP PROBABLY WAS BROKEN BECAUSE OF REPEATED USE OF THE INSTRUMENT. THE EXACT ROOT CAUSE COULD NOT BE FOUND. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.