BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5180511 · Received October 27, 2015

    Report

    Report Number
    1818910-2015-33759
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 23, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 SUBMITTED SIG FEM ADPT TORQUE WRENCH CONFIRMS THE BLACK CAP PROTECTOR HAS DISASSEMBLED FROM THE WRENCH. CAPA 000509 WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. CO 103025887 WAS RELEASED ON JANUARY 2015 TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA 000509. THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CO 103025887. NO FURTHER CORRECTIVE ACTION REQUIRED. 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.

    Description of Event or Problem · 1

    THE PLASTIC/RUBBER TIP IS MISSING FROM THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711096 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2012916

    Patients

    Seq Age Sex Outcome Treatment
    1