QUICKSET SCREW CASE COMPLETE

Description of Event or Problem

IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.

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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE QUICKSET SCREW CASE COMPLETE FOUND THREE HOLDING HOLES CHIPPED AROUND THE EDGES. ADDITIONALLY, A YELLOWISH COLOR FOREIGN SUBSTANCE WAS OBSERVED ALL OVER THE BASE TRAY. IT IS WORTH MENTIONING THAT THE LID WAS NOT RETURNED FOR EVALUATION. NO OTHER DEFECTS WERE OBSERVED. THE DEVICE EXHIBITS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND CONSTANT USAGE. NO SIGNS OF PEELING WERE OBSERVED. THE OBSERVED CHIPPED AND WORN CONDITIONS WERE 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 FOREIGN SUBSTANCE IDENTIFIED THE IFU-0902-00-721 REV L STATES, INSTRUMENTS SHOULD BE DISASSEMBLED AS NEEDED, INSPECTED FOR DAMAGE, AND ANY DEFECTIVE ITEMS SHOULD BE REMOVED FOR REPAIR. SOILED INSTRUMENTS SHOULD BE SOAKED FOR 5 MINUTES IN AN ENZYMATIC SOLUTION, THEN CLEANED WITH SOFT BRUSHES TO REMOVE DEBRIS FROM ALL SURFACES, JOINTS, AND LUMENS WHILE ACTUATING MOVING PARTS. THEN, THEY HAVE TO BE THOROUGHLY RINSED, ULTRASONICALLY CLEANED FOR 10 MINUTES IN A NEUTRAL PH DETERGENT, RINSED AGAIN, AND DRIED IMMEDIATELY. MOVING PARTS ARE LUBRICATED IF APPLICABLE, INSTRUMENTS HAVE TO BE INSPECTED FOR READINESS, AND THEN REASSEMBLED ACCORDING TO MANUFACTURER INSTRUCTIONS BEFORE STERILIZATION OR STORAGE, THEREFORE IS INSPECTED THE CAUSE CAN BE TRACED TO MAINTENANCE. A DIMENSIONAL INSPECTION AND FUNCTIONAL TESTING WERE NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE QUICKSET SCREW CASE COMPLETE WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO END OF LIFE, 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 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. ADDED: D4 LOT #, H4. CORRECTED: H3, D4 UDI #.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.