HP MBT CEM KEEL PUNCH SZ 4-7

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED ALLEGATION. THE ASSEMBLY TAB WAS FOUND BROKEN, THE FRAGMENT WAS NOT RETURNED FOR EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : A DATE CODE WAS PROVIDED, WHICH INDICATES THAT THE DEVICE WAS MANUFACTURED ON 2009. A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED SINCE A VALID FINISHED GOOD LOT NUMBER WAS NOT PROVIDED FOR THIS DEVICE. CORRECTED H3.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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. 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

IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.