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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY THE PRODUCT RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT THE DISTAL CONNECTION FEATURE HAD FRACTURED AND DETACHED FROM THE MAIN DEVICE; FRAGMENTS WERE RETURNED FOR EVALUATION. ADDITIONALLY, THE SLEEVE SUBCOMPONENT WAS MISSING. THE OBSERVED BROKEN CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, 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. REGARDING THE MISSING SUBCOMPONENT, THIS CONDITION MAY OCCUR DURING THE CLEANING/ STERILIZATION PROCESS, PARTICULARLY WHEN THE COMPONENTS ARE ASSEMBLED OR DISASSEMBLED. AS THESE PROCEDURES ARE OFTEN REPEATED, THERE IS AN INCREASED RISK OF COMPONENTS GOING MISSING. HOWEVER, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. A DIMENSIONAL INSPECTION AND FUNCTIONAL TESTING WERE NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE QUICKSET ACE GRATER HANDLE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 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 A DEVICE HISTORY RECORD (DHR) REVIEW OR MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE DATE CODE (A0607) PROVIDED IS NOT A VALID FINISHED GOODS LOT#

Description of Event or Problem

IT WAS REPORTED THAT THE GRATER TOP PIECE HAD BROKEN OFF OF ONE OF THEM. THE HOSPITAL STATED THAT THE OTHER COULD NOT BE CLEANED BECAUSE IT COULD NOT BE TAKEN APART.