BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT OSCILLATING SAW

    MDR report key: 104928 · Received July 10, 1997

    Report

    Report Number
    2219689-1997-00365
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 10, 1997
    Report Date
    July 9, 1997
    Manufacturer
    SURGIQUIP INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OSCILLATING SAW CASING CRACKED IN THE FRONT NEAR THE BLADE. THE BLADE OSCILLATED ERRATICALLY AND SCORED THE BONE. ANOTHER SAW WAS READILY AVAILABLE AND USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT OSCILLATING SAW INSTRUMENT HWE SURGIQUIP INC. NA BXIUD

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other