BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL

    MDR report key: 3983107 · Received August 6, 2014

    Report

    Report Number
    0001811755-2014-02811
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT THAT THE HANDLE WAS LOOSE AND BROKEN WAS CONFIRMED THROUGH THE VISUAL INSPECTION. AS REPORTED IN THE EVENT DESCRIPTION THE DEVICE WAS USED WITH A MALLET. STRIKING THE DEVICE WITH A MALLET CAN CAUSE OR CONTRIBUTE TO THE FAILURE OF THE DEVICE. STRIKING THE DEVICE WITH A MALLET IS CONTRARY TO THE IFU; ¿DO NOT APPLY ANY PHYSICAL IMPACT TO THE NAVIGATED INSTRUMENT, SUCH AS WITH A MALLET OR A SIMILAR TOOL. ANY IMPACT WILL CAUSE PRODUCT DAMAGE OR OPERATIONAL FAILURE DUE TO BATTERY MOVEMENT.¿ THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.

    Description of Event or Problem · 1

    DURING A SPINAL FUSION PROCEDURE AT THE USER FACILITY, IT WAS REPORTED THAT THE HANDLE OF THE AWL BROKE APART WHILE THE SURGEON WAS HAMMERING ENTRY POINTS OR PUSHING ON THE TOOL DURING USE. IT WAS UNKNOWN WHETHER ANY PLASTIC SHARDS OR POWDER FELL INTO THE SURGICAL SITE; HOWEVER, IF SO, THE SURGEON REPORTED IT WOULD HAVE BEEN REMOVED WHEN THE SITE WAS IRRIGATED. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    DURING A SPINAL FUSION PROCEDURE AT THE USER FACILITY, IT WAS REPORTED THAT THE HANDLE OF THE AWL BROKE APART WHILE THE SURGEON WAS HAMMERING ENTRY POINTS OR PUSHING ON THE TOOL DURING USE. IT WAS UNKNOWN WHETHER ANY PLASTIC SHARDS OR POWDER FELL INTO THE SURGICAL SITE; HOWEVER, IF SO, THE SURGEON REPORTED IT WOULD HAVE BEEN REMOVED WHEN THE SITE WAS IRRIGATED. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461312 AWL NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1