COUPLER AC ZOOM

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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: DESCRIPTION OF FAULT ACCORDING TO WOM TECHNICIAN: BROKEN LENS INSIDE THE OPTICAL SYSTEM - MOST LIKELY DUE TO A FALL. OBJECTIVE IS NOT REPAIRABLE.    BROKEN (2+ PIECES) : BROKEN/FRACTURED, VISUAL : DEFORMED/BENT. 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 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 DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS NOT FUNCTIONING CORRECTLY. DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN THE OPTICAL SYSTEM. THEY USED ANOTHER COUPLER TO COMPLETE THE CASE WITH A DELAY OF TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.