BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE IMPACTION HANDLE

    MDR report key: 4844322 · Received June 15, 2015

    Report

    Report Number
    1818910-2015-23565
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    June 13, 2015
    Report Date
    June 30, 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 UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE 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

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES LOCKING TRIGGER HAS SNAPPED OFF. THE INVESTIGATION CONFIRMED THAT THE LEVER HAD BROKEN AS REPORTED. IT SHOULD BE NOTED THAT A FIELD SAFETY NOTICE WAS ISSUED WITH REGARD TO THE LEVER BREAKING; STATING THAT TO REDUCE THE POSSIBILITY OF LEAVING FRAGMENTS IN PATIENTS TO ADHERE TO THE IFU WHICH INCLUDE INSPECTING THE INSTRUMENTS TO ENSURE THAT NO INSTRUMENTS OR PIECES OF INSTRUMENTS ARE LEFT IN THE SURGICAL SITE PRIOR TO CLOSURE THE COMPLAINT SHALL BE CLOSED AS UNDER INVESTIGATION AND THE PRODUCT WILL BE SENT TO THE SUPPLIER FOR CORRECTIVE ACTION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. ONCE THE SUPPLIER REPORT IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND UPDATED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LOCKING TRIGGER HAS SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389642 ATTUNE IMPACTION HANDLE GENERAL/MISC INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. NW147386

    Patients

    Seq Age Sex Outcome Treatment
    1