QUICKSET

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. H11 ADDITIONAL NARRATIVE: H3, H6: 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. 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 DEVICE FOUND ROUNDING OF CUTTING EDGES. ADDITIONALLY, THE TOP OF THE SURFACE WAS DEFORMED. IT IS NOT UNREASONABLE THAT THE CONDITION IDENTIFIED IN VISUAL ANALYSIS WOULD CONTRIBUTE TO A DULL CONDITION. THEREFORE, WE ARE ABLE TO CONFIRM DULLNESS WITH DAMAGE OBSERVED, AS THIS KIND OF EVIDENCE INDICATES REPEATED USE OF THE DEVICE. THE OBSERVED DEFORMATION CONDITION OF THE DEVICE COULD BE CONSISTENT WITH THE APPLICATION OF LEVERAGE, BENDING, OR LATERAL TORSIONAL LOADS ON AN INSTRUMENT , RESULTING IN STRESSES THAT MAY HAVE EXCEEDED THE INTENDED USE CONDITIONS OF THE DEVICE. HOWEVER, DUE TO THE LOW FREQUENCY OF THIS OCCURRENCES AND NOT SUSPECTING ANY DESIGN ISSUE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE IN CLINICAL PRACTICE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. 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 QUICKSET ACE GRATER HEAD WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE REAMERS WERE DULL AND NEED TO BE REPLACED. THE EVENT DID NOT HAPPEN IN SURGERY. UPON MANUFACTURERS INVESTIGATION THE DEVICE WAS NOTED TO BE DEFORMED.