BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 4222394 · Received November 4, 2014

    Report

    Report Number
    1818910-2014-31071
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    (B)(4). EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT HAS CRACKED AND BECOME DISASSEMBLED FROM THE WRENCH. THE FRACTURED PLASTIC PROTECTOR WAS RETURNED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DISASSOCIATED PROTECTIVE CAP. ECO249156 WAS PREVIOUSLY IMPLEMENT FOR THIS FAILURE MODE. THE CURRENT COMPLAINT SAMPLE PRODUCT WAS MANUFACTURED AFTER THE IMPLEMENTATION OF ECO249156. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    THE BLACK PLASTIC PIECE ON THE TIP OF THE FEMORAL ADAPTOR TORQUE WRENCH IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708255 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. A1008

    Patients

    Seq Age Sex Outcome Treatment
    1