THREAD-TUBE F/PELVIC C-CLAMP

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. H3, H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 03.306.008 LOT # 96P2421 IT WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES /MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE PRODUCT WAS RELEASED ON: 06/05/2021 MANUFACTURING SITE:(B)(4). THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE COMPONENTS OF THE PELVIC C-CLAMP HAS EVIDENCE OF HEAVY USE AND WEAR, ALSO, THE COMPONENTS HAVE A TIGHT FIT AT THE MOMENT TO BE ATTACHED CAUSING DIFFICULT TO ASSEMBLE. NO OTHER ISSUES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE FUNCTIONAL TEST WAS PERFORMED, THE COMPONENTS WERE TRIED TO ATTACHED, THE COMPONENTS CANNOT BE ASSEMBLE. THE DEVICES CANNOT BE ASSEMBLE, THEREFORE THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE THREAD-TUBE F/PELVIC C-CLAMP WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: FOLLOWING INVESTIGATION WAS PERFORMED BY JABIL. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE THREAD-TUBE F/PELVIC C-CLAMP STRIPPED ON THE THREADS. THE RETURNED INSTRUMENT WAS NOT IN A GOOD CONDITION. THE TWO ARTICLES OF 03.306.008 WERE NOT INCLUDED IN THE FUSIONAL TEST, HOWEVER THE STRIPPED CONDITION CAN INFLUENCE ON THE DEVICE INTERACTION ALLEGATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO EXCESSIVE/UNINTENDED FORCES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE THREAD-TUBE F/PELVIC C-CLAMP (03.306.008) WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INTRAOPERATIVELY SEVERAL DEVICE MALFUNCTIONS OCCURRED. SINCE THE MATERIAL WAS RECEIVED, THE CONNECTION BETWEEN THE INTERIOR AND EXTERIOR RAILS HAS BEEN DIFFICULT. THEN THE THREADED SLEEVE GOT STUCK IN THE LOWER ARM. THE METAL INSERT IS SEPARATED FROM THE LOWER ARM. THE 2ND THREADED SLEEVE ALSO SEIZED UP. TO DATE THE EQUIPMENT IS UNUSABLE. THE MATERIAL IS DAMAGED BECAUSE THE SURGEONS HAD TO FORCE RELEASE ALL THE PARTS THAT WERE BLOCKED. A SOLUTION HAD TO BE FOUND TO REMOVE THE MATERIAL BLOCKED IN THE PATIENT'S PELVIS. THERE WAS NO CHANGE OF SURGICAL TECHNIQUE. THE SYSTEM WAS USED FOR RETAINING BONES DURING PELVIS SURGERIES. AFTER SOME USES, THE SYSTEM DID NOT USUALLY SLIDE AS USUAL. PROGRESSIVELY WITH USES, A PART OF THE SYSTEM WAS JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING THIS EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER. THE SURGEONS HAD ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) THREAD-TUBE F/PELVIC C-CLAMP THIS IS REPORT 1 OF 13 FOR COMPLAINT (B)(4).

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. H10 ADDITIONAL NARRATIVE: H3, H6: THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.