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: H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY THE COMPLAINT DEVICE WAS RECEIVED AT THE MANUFACTURING SITE AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: - GRASPING MECHANISM DEFECTIVE / WORN OUT. - RESIDUES IN THE OPTICAL CAPSULE. -DEVICE INTERACTION (2+ DEVICES): WILL NOT HOLD/RETAIN, VISUAL: FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. PER SERVICE REPORTS, THIS COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE FAULTY PARTS WERE 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.

Description of Event or Problem

IT WAS REPORTED THAT THE COUPLER AC FFL 19 DEVICE WAS BENT AND COULD NOT OPEN OR CLOSE. THE DAMAGE WAS IDENTIFIED DURING STERILE PROCESSING BEFORE THE COUPLER WAS STERILIZED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.