BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPSY SAW 115V

    MDR report key: 3010596 · Received March 19, 2013

    Report

    Report Number
    0001811755-2013-00547
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT THE COMPLAINT WAS DUPLICATED, THE DEVICE WOULD NOT RETAIN THE BLADE. THE SET SCREW WAS FOUND TO BE STRIPPED AND STUCK IN PLACE, WHICH WOULD NOT ALLOW FOR THE SCREW TO BE TIGHTENED AND LOCK IN THE BLADE. THE PRODUCT IS BEING DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPSY SAW 115V WOULD NOT RETAIN THE BLADE DURING AN AUTOPSY. THE BLADE CAME OFF DURING USE AND FELL INTO THE BODY. A BACKUP WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114948 AUTOPSY SAW 115V SAW, POWERED, AND ACCESSORIES HAB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1