BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 4460613 · Received January 28, 2015

    Report

    Report Number
    1818910-2015-12071
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT HAS CRACKED AND BECOME DISASSEMBLED FROM THE WRENCH. FURTHER EXAMINATION REVEALED A LOOSE SCALE PLATE. CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. CO 103025887 HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CO 103025887. NO FURTHER CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    TORQUE WRENCH BLACK TIP CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64589 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC SO2001708

    Patients

    Seq Age Sex Outcome Treatment
    1