COUPLER AC FFL 19

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, 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. H11 ADDITIONAL NARRATIVE: D9, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN KNEE UNSPECIFIED SURGICAL PROCEDURE THE WHILE USING THE COUPLER AC FFL DEVICE THE MONITOR WAS FOCUSED SO THAT THE MONITOR EDGES WERE ALIGNED, IT WAS OUT OF FOCUS WITH THE OBJECT, AND WHEN THE MONITOR WAS FOCUSED WITH THE OBJECT, THE MONITOR EDGES APPEARED DISTORTED. EVEN IN SUCH A STATE, THE CAMERA COULD BE USED, SO THE SURGEON CONTINUED TO SURGERY. HOWEVER, THE SURGEON COULD NO LONGER CONTINUE THE OPERATION BECAUSE THE CAMERA HEAD IN QUESTION BEGAN MAKING A CONTINUOUS SERIES OF MOVEMENTS THAT SEEMED TO BE TRYING TO AUTO-FOCUS THE CAMERA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED WITHIN A THIRTY MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, 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. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. GIVEN THAT NO SERIAL NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. IF THE SERIAL NUMBER BECOMES AVAILABLE, THE MRE REVIEW WILL BE PERFORMED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE COMPLAINT DEVICE 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 J&J MEDTECH ORTHOPAEDICS 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.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: FUNCTIONAL: DOES NOT FUNCTION. PER SERVICE REPORT, THIS COMPLAINT WAS CONFIRMED. THE CLAMP WERE REPLACED TO RESOLVE THE ISSUES. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO FAULTY PARTS. 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 J&J MEDTECH ORTHOPAEDICS 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO NON-CONFORMANCE WAS IDENTIFIED. D9, D4, H4: THE DEVICE RETURN DATE, COMPLETE UDI AND DATE OF MANUFACTURE HAVE BEEN ADDED.