BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE

    MDR report key: 1060187 · Received May 19, 2008

    Report

    Report Number
    1060187
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 18, 2008
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    OSCILLATING SAW BLADES (SIX) BROKE CLEANLY OFF OF SHAFT WITHOUT FRAGMENTING REPEATEDLY WITH VERY LITTLE USE. SIX BLADES WERE THEN USED WITH THE SAME RESULTS. DR. REQUESTED A DIFFERENT STYLE OF OSCILLATING BLADE, WHICH CONTINUED TO FUNCTION WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCILLATING SAW BLADE SAW BLADE, OSCILLATING DWH STRYKER INSTRUMENTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR