BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR TORQUE LIMITING ATTACHMENT

    MDR report key: 12313764 · Received August 12, 2021

    Report

    Report Number
    2939274-2021-04620
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Report Date
    July 13, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982071835
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: REPORTER IS A J&J EMPLOYEE. 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. VISUAL INSPECTION: THE HANDLE FOR TORQUE LIMITING ATTACHMENT (P/N: 03.110.005, LOT #: 8881095) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TORQUE LIMITING ATTACHMENT WAS RECEIVED DISASSEMBLED AS THE MUSHROOM HEAD SCREW WAS MISSING. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: THERE WAS CONCLUSIVE EVIDENCE THAT THE RETURNED DEVICE WAS MISSING COMPONENTS, SO THE DIMENSIONAL INSPECTION WAS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. TLA HANDLE: SE_081645, REV. N/M. PILZKOPFSCH: SE_095174, REV. H. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT CONDITION WAS CONFIRMED FOR THE HANDLE FOR TORQUE LIMITING ATTACHMENT (P/N: 03.110.005, LOT #: 8881095) AS THE RETURNED DEVICE WAS MISSING A COMPONENT. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO DEVICE MAINTENANCE. 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 HISTORY LOT - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE, IT WAS OBSERVED THAT THE HANDLE FOR TORQUE LIMITING ATTACHMENT WAS FOUND TO BE BROKEN. THIS REPORT IS FOR ONE (1) HANDLE FOR TORQUE LIMITING ATTACHMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209911 HANDLE FOR TORQUE LIMITING ATTACHMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.110.005 8881095 10886982071835

    Patients

    Seq Age Sex Outcome Treatment
    1