BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5577631 · Received April 14, 2016

    Report

    Report Number
    1818910-2016-17357
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Date of Event
    February 18, 2016
    Report Date
    April 13, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. UDI: (B)(4). 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

    EXAMINATION OF THE SUBMITTED SIG FEM ADPT TORQUE WRENCH CONFIRMS THE BLACK CAP PROTECTOR HAS DISASSEMBLED FROM THE WRENCH. (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) WAS RELEASED JANUARY 2015 TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF (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

    SOCKET CAP DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231680 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL HXC DEPUY ORTHOPAEDICS, INC. SO2008134

    Patients

    Seq Age Sex Outcome Treatment
    1