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 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: E3: REPORTER IS A J&J SALES REPRESENTATIVE. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION 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: - RESIDUES IN THE OPTICAL CAPSULE. 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 IMPROPER MAINTENANCE WAS IDENTIFIED AS THE ROOT CAUSE FOR THE DEVICE FAILURE DURING THE SERVICE EVALUATION. 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: MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING.

Description of Event or Problem

IT WAS REPORTED THAT DURING WASHING AND CLEANING IT WAS OBSERVED THAT THE COUPLER AC FFL 19 DEVICE WAS DROPPED AND DAMAGED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THERE WAS RESIDUE ON THE OPTICAL CAPSULE. DURING VISUAL ASSESSMENT IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.