BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5200655 · Received November 4, 2015

    Report

    Report Number
    1818910-2015-34392
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT HAS BECOME DISASSEMBLED FROM THE WRENCH. CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) 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 (B)(4) 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 TORQUE WRENCH CAP CAME UNGLUED AND GOT LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731829 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. A1107

    Patients

    Seq Age Sex Outcome Treatment
    1