ATTUNE RP TRL BLT SZ 3-5 POR

Description of Event or Problem

IT WAS REPORTED THAT THE SURGEON DIDN¿T CONICAL TEAM BEFORE USING IMPACTION TIP AND WING OF THE BULLET BROKE OFF. NO PATIENT IMPACT.

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.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: SURGEON DIDN¿T CONICAL TEAM BEFORE USING IMPACTION TIP AND WING OF THE BULLET BROKE OFF. NO PATIENT IMPACT. TRAY HAS BEEN MARKED AS HAVING A BROKEN INSTRUMENT IN AND WILL RETURN WITH THE LOAN SET. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THE ATTUNE RP TRL BLT SZ 3-5 POR WAS BROKEN. THE BROKEN FRAGMENT WAS RETURNED FOR EVALUATION. THE INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED EVENT. NO OTHER PROBLEM IDENTIFIED. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES AND FAILURE TO FOLLOW THE INSTRUCTIONS MENTIONED IN THE IFU BY USING DEVICE IN OFF LABEL MANNER. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE RP TRL BLT SZ 3-5 POR WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES 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 LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # :(B)(4).INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. REVIEW OF THE PROVIDED PHOTOGRAPHS REVEALED THAT THE PROXIMAL PORTION OF THE TIBIAL PUNCH HAS BROKEN OFF. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. REVIEW OF THE PROVIDED PHOTOGRAPHS REVEALED THAT THE PROXIMAL PORTION OF THE TIBIAL PUNCH HAS BROKEN OFF. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.