BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 4470222 · Received January 30, 2015

    Report

    Report Number
    1818910-2015-12271
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    January 12, 2015
    Report Date
    January 12, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED SIG FEM ADPT TORQUE WRENCH CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT REMAINS ATTACHED TO THE WRENCH, BUT IS LOOSE AND SPINS. (B)(4) WAS PREVIOUSLY INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) HAS BEEN INITIATED TO CHANGE THEN 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 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. (B)(4).

    Description of Event or Problem · 1

    PLASTIC PIECE ON TOP OF THE INSTRUMENT IS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70827 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. A0211

    Patients

    Seq Age Sex Outcome Treatment
    1