BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE HANDLE QUICK COUPLING/LONG

    MDR report key: 12366477 · Received August 25, 2021

    Report

    Report Number
    2939274-2021-04894
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Report Date
    July 28, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982072115
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: PART: 03.111.012-US; LOT: 9100314; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 13 OCTOBER 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE COMPLAINT DEVICE HANDLE FOR QUICK COUPLING WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. THE RETURNED DEVICE HAD BLUNT EDGES ON ITS CONNECTING END AND THE METALLIC CAP ON THE DISTAL END HAD IMPACTION MARKS. ONE OF THE BALL BEARINGS ON THE KNOB WAS NOT COMPLETELY CLOSING IN WHEN THE SLEEVE WAS MOUNTED ON THE KNOB, THIS COULD BE DUE TO THE CIRCULAR INDENTATION LEFT ON THE SLEEVE BY THE BALL OVER YEARS OF USE. FUNCTIONAL TEST: A FUNCTIONAL TEST OF COULD NOT BE PERFORMED AS THE QUICK CONNECT HANDLE WAS NOT RETURNED WITH A MATING DEVICE. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO, UNABLE TO PERFORM FUNCTIONAL TEST TO EVALUATE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: ACCORDING TO SCHIEBEHUELSE (MANUFACTURED), MEASURED DIMENSION: OUTER DIAMETER NEAR THE PROXIMAL END: (CONFORMING); INNER DIAMETER NEAR THE CONNECTING END: (CONFORMING). DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE DRAWINGS RELEASED DURING THE MANUFACTURING PERIOD AND CURRENT PERIOD WAS REVIEWED: HANDLE, LONG, WITH QUICK COUPLING, (CURRENT); HANDLE, LONG, W/QUICK COUPLING, (MANUFACTURED); FZ GRUNDKOERPER ¿ DREHEN, (CURRENT); SCHIEBEHUELSE (MANUFACTURED); SCHAFT (MANUFACTURED); KNOB (MANUFACTURED). THE PART 03.111.012 WAS REDESIGNED IN THE YEAR 2017, CORRESPONDING TO CHANGE ORDER. PLEASE REFER TO THE CURRENT DRAWINGS FOR THE PART. COMPLAINT CONFIRMED: THE COMPLAINT CONDITION CANNOT BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE QUICK CONNECT HANDLE WAS RECEIVED AT CQ WITHOUT ANY QUICK CONNECT INSTRUMENT TO EVALUATE THE COMPLAINT CONDITION, HENCE THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. THE OVERALL COMPLAINT WOULD BE CONFIRMED SINCE THERE WERE OTHER ISSUES WITH THE DEVICE. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE SURGERY THE QUICK CONNECT HANDLE LATCHES ON QUICK CONNECT INSTRUMENT AND WILL NOT RELEASE. THE INSTRUMENTS GET STUCK DOWN IN THE CONNECTION PORTION TO THE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) SILICONE HANDLE QUICK COUPLING/LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264171 SILICONE HANDLE QUICK COUPLING/LONG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.111.012 9100314 10886982072115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - EXTRACTION INSTRUMENTS: TRAUMA| UNK - EXTRACTION INSTRUMENTS: TRAUMA