BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2123334 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02071
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE TO INTERNAL COMPONENTS WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT FOR SERVICE BECAUSE, IT WAS RUNNING ON ITS OWN WITHOUT ACTIVATION DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY; NO ADVERSE EVENT WAS REPORTED.

    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