BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRONIER

    MDR report key: 830843 · Received March 19, 2007

    Report

    Report Number
    MW1042304
    Event Type
    Other
    Date Received
    March 19, 2007
    Date of Event
    February 20, 2007
    Report Date
    March 19, 2007
    Manufacturer
    TRONIER INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT HUMERAL HEAD ARTHROPLASTY, A 3.5MM SCREW DRIVER -HEX HEAD- END BROKE OFF IN FIXATION SCREW OF THE GLENOSHERE IMPLANT. IT IS RECESSED BUT UNABLE TO RETRIEVE BROKEN OFF PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRONIER MWB 3.5 MM SCREWDRIVER HXX TRONIER INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other