BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 3940590 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23653
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE TORQUE WRENCH ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED. THE PRODUCT LOT CODE REQUIRED TO IDENTIFY THE MANUFACTURE DATE AND DESIGN REVISION WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE AGAINST PRODUCT CODE 961673 FOUND ADDITIONAL REPORTS OF BREAKAGE. THERE ARE PREVIOUS REPORTS OF THE BLACK PLASTIC PROTECTOR COMPONENT BREAKING AND THE HEX BARREL BREAKING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE INSTRUMENT FEATURE THAT BROKE WITHOUT THE INSTRUMENT TO EXAMINE OR THE PROVIDED INFORMATION. (B)(4) WAS PREVIOUSLY INITIATED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTION FOR BLACK PLASTIC PROTECTOR COMPONENT. BASED ON THE INABILITY TO IDENTIFY THE FAILURE MODE/BREAKAGE, THE NEED FOR ADDITIONAL CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    TORQUE WRENCH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419544 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1