COUPLER AC FFL 22

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: INVESTIGATIONAL SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: DESCRIPTION OF FAULT ACCORDING TO WOM TECHNICIAN: LENS SYSTEM SPRING. VISUAL: FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. PER SERVICE REPORTS, THIS COMPLAINT WAS CONFIRMED. BASED ON SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, THE DEVICE WAS FOUND TO BE NON-REPAIRABLE, AND IT WAS DISCARDED. 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 REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER, AND NO NON-CONFORMANCE WAS IDENTIFIED.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN USING THE COUPLER AC FFL 22 DEVICE, THE IMAGE WAS POOR, AND THE COUPLER MAY HAVE SOME WATER THAT HAD LEAKED INSIDE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.