BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2042792 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01026
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE SERIAL NUMBER WAS NOT PROVIDED; WITHOUT THE SERIAL NUMBER, THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A STRYKER MICRO SAGITTAL SAW WAS CALLED IN FOR REPAIR BECAUSE, IT WOULD NOT SHUT OFF DURING A PROCEDURE. NO ADVERSE CONSEQUENCE WAS REPORTED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK