BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 3974883 · Received August 4, 2014

    Report

    Report Number
    1818910-2014-24855
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED TORQUE WRENCH CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT HAS FRACTURED AND HAS SEPARATED FROM THE WRENCH. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURED PROTECTIVE CAP. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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. 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

    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

    TORQUE WRENCH BROKE WHILE TIGHTENING THE FEMORAL ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453343 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2012377

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR