BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE IMPACTION HANDLE

    MDR report key: 7107565 · Received December 12, 2017

    Report

    Report Number
    1818910-2017-51247
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    HWA
    UDI-DI
    10603295423324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES IT WAS REPORTED THAT THE RED BUTTONS/THUMB LATCHES BROKE OFF. 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 WITH A JUSTIFIED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY ==> CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES IT WAS REPORTED THAT THE RED BUTTONS/THUMB LATCHES BROKE OFF. 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 WITH A JUSTIFIED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEVICE HISTORY LOT ==> NULL. DEVICE HISTORY REVIEW ==> NULL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RED BUTTONS/THUMB LATCHES BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888039 ATTUNE IMPACTION HANDLE ATTUNE INSTRUMENTS : HANDLES HWA DEPUY IRELAND 9616671 NW131964 10603295423324

    Patients

    Seq Age Sex Outcome Treatment
    1