BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2140737 · Received June 15, 2011

    Report

    Report Number
    1811755-2011-02169
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT FOR ANALYSIS BECAUSE METAL FLAKES WERE COMING OUT OF THE DEVICE DURING A PROCEDURE. FLAKES WERE NOTED IN THE SURGICAL SITE BUT WERE SUCCESSFULLY CLEANED OUT. NO MED TREATMENT WAS PROVIDED AS A RESULT OF THIS EVENT. A REPLACEMENT DEVICE WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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