BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2140441 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02231
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED THROUGHOUT THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. A READILY AVAILABLE REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY DELAY. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    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