BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE IMPACTION HANDLE

    MDR report key: 4913371 · Received July 14, 2015

    Report

    Report Number
    1818910-2015-25666
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES THE LEVER OF THE ATTUNE HANDLE BROKE WHILE IMPACTING. THE INVESTIGATION CONFIRMED THAT THE LEVER HAD BROKEN AS REPORTED. IT SHOULD BE NOTED THAT A FIELD SAFETY NOTICE WAS ISSUED 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 TO CAPA; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. 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

    ADDITIONAL NARRATIVE: 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

    THE LEVER OF THE ATTUNE HANDLE BROKE WHILE IMPACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454664 ATTUNE IMPACTION HANDLE KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. NW143591

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR