ACTIS

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. ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE FIXATION POST OF THE ACTIS BROACH SIZE 6 HAS SCRATCHES AND WAS SEVERELY DEFORMED. ADDITIONALLY, THE SAMPLE EXHIBITS SIGNS OF HEAVY USE. THE OBSERVED CONDITION OF THE FIXATION POST CAN BE ATTRIBUTED TO UNINTENDED USE ERROR, WITH THE DAMAGE LIKELY RESULTING FROM OFF-AXIS ASSEMBLY, PRYING MOTION WHILE DEVICE IS ASSEMBLED AND IMPACTION FORCES COMBINED WITH HANDLE NOT BEING FULLY SECURED ONTO THE BROACH. PROPER HANDLING AND ADHERENCE TO THE APPROVED USE OF THE DEVICE CAN DIMINISH THE RISK OF FAILURE. A FUNCTIONAL TEST WAS PERFORMED WITH MATTING COMPONENT RETURNED MI CALCAR REAMER SHAFT. IT WAS FOUND THAT DUE TO THE SCRATCHES ON BOTH DEVICES, THEY PRESENT RESISTANCE WHEN ASSEMBLING AND DISASSEMBLING. 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 ACTIS BROACH SIZE 6 WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. 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 MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT THE CALCAR PLANER SHAFT IS CHEWED UP ON THE INSIDE WHICH CHEWED UP THE NECK ON THE 6 ACTIS BROACH. DID NOT EFFECT PATIENT.