BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC BLADE

    MDR report key: 2809439 · Received October 24, 2012

    Report

    Report Number
    MW5027378
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS GETTING READY TO USE THE MEDTRONIC ABRADER WITH THE 60 DEGREE 4MM BLADE. JUST BEFORE PLACING IT IN THE PT¿S NOSE, HE NOTICED A WIRE STICKING OUT. WHEN HE TESTED THE ABRADER, WITHOUT TOUCHING THE PT, THE TIP BROKE OFF. THE BLADE WAS REMOVED FROM THE STERILE FIELD AND REPLACED WITH A NEW ONE. HE COMPLETED THE SURGERY WITHOUT ANY COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC BLADE RAD 60 BLADE, 4MM KTG MEDTRONIC XOMED, INC. H8057101

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR