INSERTION HANDLE F/AIMING ARM F/VA-LCP C

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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: CORRECTED: G1. H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND TO BE DAMAGED FROM THE INNER THREADS. A FUNCTIONAL TEST WAS PERFORMED WITH THE MATING DEVICE (CONNECT-BOLT F/AIMING ARM F/PERIARTI-AIM) AND FOUND DIFFICULTIES IN ASSEMBLING; LIKELY DUE TO DAMAGE OBSERVED ON THE THREADS THEREFORE, THE REPORTED ALLEGATION CAN BE CONFIRMED. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE INSERTION HANDLE F/AIMING ARM F/VA-LCP C WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: PART# 03.231.001. LOT # 3828500. MANUFACTURING SITE: WERK HAGENDORF. MANUFACTURING DATE: 27.SEP.2011. EXPIRATION DATE: N/A. SUPPLIER: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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

ATTEMPTING TO SCREW BOLT FROM VA-LCP CODYLAR AIMING ARM (03.231.003) - BOLT 03.120.030 - INTO INSERTION HANDLE FOR AIMING ARM (03.231.001) - AND WAS NOT THREADING IN. LOOKED LIKE DAMAGED THREAD ON INSERTION HANDLE. FROM LOAN SET ZXNZTR0803 - EQUIPMENT NUMBER 3000073664.

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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: D9 THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.