RIGIDFIX

Additional Manufacturer Narrative

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, 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: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE NOT RETURNED TO DEPUY SYNTHES AND UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WAS IDENTIFIED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PINS ON THE SIDE OF THE DRILL BIT FOR THE FERRULES BROKE OFF FOR (2) RGDFX CRVE ST ACL PLA XPIN SYS DEVICES. IT WAS REPORTED THAT TWO KITS WITH THE SAME LOT NUMBER WERE USED. THE FIRST DRILL BIT WAS COMPLETELY STUCK IN THE FERRULE AND WOULDN'T COME OUT AFTERWARD. WHEN THE DRILL WAS RETRIEVED, THE FERRULE CAME OUT WITH IT. IT TURNED OUT THAT THE PINS HAD BROKEN OFF THE DRILL BIT. THE SECOND KIT USED A NEW FERRULE, WHICH WAS EXTRA WET. THIS ONE WAS DRILLED PROPERLY, AND THE TIPS WERE CHECKED; THEY WERE STILL THERE. WHEN DRILLING THE SECOND FERRULE, IT DIDN'T GO ALL THE WAY IN. IT THEN TURNED OUT THAT THE PINS HAD BROKEN OFF THERE AS WELL. THE REMNANTS OF THE TIPS STILL HAD A LITTLE BIT OF GRIP, BUT THAT QUICKLY DISAPPEARED. THE FERRULE WAS HAMMERED IN THE REST OF THE WAY (THERE WASN'T A THIRD KIT AVAILABLE).THE CROSS PINS WENT IN WITHOUT ANY PROBLEMS, AND THE CRUCIATE LIGAMENT WAS ALSO SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE KIT BOXES WERE RETAINED, BUT UNFORTUNATELY NOT THE DRILL BITS THEMSELVES. IT WAS REPORTED THAT DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY 15-20 MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

Additional Manufacturer Narrative

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, 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: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME.