ATTUNE RP TRL BLT SZ 6-8 POR

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- DURING A VELYS RAS TOTAL KNEE PROCEDURE THE ATTUNE RP TIBIAL KEEL PUNCH BROKE A WING OFF DURING IMPACTION. THE REMNANT PIECE WAS RETRIEVED EASILY, THERE WAS NO ADVERSE IMPACT TO THE PATIENT, NO DELAY TO SURGERY AND THE CASE CONTINUED ON TO COMPLETION UNEVENTFULLY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE ATTUNE RP TRL BLT SZ 6-8 POR HAD ONE OF THE WINGS BROKEN. FRAGMENT WAS RETURNED FOR EVALUATION. THE OBSERVED CONDITION OF THE DEVICE CAN BE ATTRIBUTED TO A COMBINATION OF HEAVY USE AND EXPOSURE TO UNINTENDED FORCES DURING REPEATED ATTEMPTS AT ASSEMBLY AND DISASSEMBLY IN THE BASE TRIAL. THESE FORCES COULD INCLUDE IMPACTIONS, OFF-AXIS ASSEMBLY WHILE IMPACTING, OR PRYING MOTIONS USED WHEN REMOVING THE RP PUNCH. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. 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 ATTUNE RP TRL BLT SZ 6-8 POR WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR, AND 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 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). 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.

Description of Event or Problem

DURING A VELYS RAS TOTAL KNEE PROCEDURE THE ATTUNE RP TIBIAL KEEL PUNCH BROKE A WING OFF DURING IMPACTION. THE REMNANT PIECE WAS RETRIEVED EASILY, THERE WAS NO ADVERSE IMPACT TO THE PATIENT, NO DELAY TO SURGERY AND THE CASE CONTINUED ON TO COMPLETION UNEVENTFULLY.

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. H11 ADDITIONAL NARRATIVE: ADDED: D9. 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). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, "DURING A VELYS RAS TOTAL KNEE PROCEDURE THE ATTUNE RP TIBIAL KEEL PUNCH BROKE A WING OFF DURING IMPACTION. THE REMNANT PIECE WAS RETRIEVED EASILY, THERE WAS NO ADVERSE IMPACT TO THE PATIENT, NO DELAY TO SURGERY AND THE CASE CONTINUED ON TO COMPLETION UNEVENTFULLY." THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT ATTUNE RP TRL BLT SZ 6-8 POR HAD BROKEN. POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY USE OF EXCESSIVE FORCE IN A PRYING MOTION AND OVERLOAD OF THE MATERIAL. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE RP TRL BLT SZ 6-8 POR WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, CAUSE TRACE TO USER ERROR AND 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 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 MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.