BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGG BUR 4.0MM

    MDR report key: 1182318 · Received September 30, 2008

    Report

    Report Number
    9616696-2008-00053
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AS YET FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BUNIONECTOMY, SMALL PIECES OF METAL WERE SEEN TO FALL INTO THE SURGICAL SITE DURING USE OF THE BUR PRODUCT. THE SURGEON REMOVED THE PIECES OF METAL USING A FORCEPS AND IRRIGATION. THE SURGEON DOES NOT HAVE ANY CONCERNS THAT PIECES OF METAL REMAIN BEHIND IN THE BODY. IT IS NOT KNOWN IF ANY X-RAY WAS TAKEN TO MAKE THIS DETERMINATION. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGG BUR 4.0MM DEVICE DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 08181017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK