BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2233167 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02635
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE REPLACEMENT DEVICE WITHOUT ANY CLINICALLY SIGNIFICANT PROCEDURE 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