BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 2520941 · Received April 2, 2012

    Report

    Report Number
    MW5024885
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Date of Event
    March 30, 2012
    Report Date
    April 2, 2012
    Manufacturer
    BIOMET
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS INSERTING A SCREW INTO THE GLENOID COMPONENT DURING RIGHT TOTAL SHOULDER ARTHROPLASTY, AND THE TIP OF THE SCREWDRIVER BROKE. THE PIECE REMAINED WITHIN THE SOCKET OF THE SCREW HEAD AND COULD NOT BE RELEASED WITH ANY INSTRUMENT, THUS THE ANSPACH WAS BROUGHT OUT AND USED TO BUR THIS DOWN FLUSH WITH THE SURFACE OF THE SCREW SO AS NOT TO OBSTRUCT SEATING OF THE POLYETHYLENE COMPONENT. THE PT HAS NO FURTHER COMPLICATIONS AND LEFT OPERATING ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SCREWDRIVER HXX BIOMET 424495 902760

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other