BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 2639491 · Received June 26, 2012

    Report

    Report Number
    MW5025988
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    June 24, 2012
    Report Date
    June 26, 2012
    Manufacturer
    BIOMET
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMED THE BELOW PROCEDURE ON (B)(6) 2012 THAT INCLUDED THE FOLLOWING EVENT: DURING HYBRID HEAD AND NECK REPLACEMENT CONSTRAINED RIGHT TOTAL HIP ARTHROPLASTY WITH INTERNAL FIXATION OF GREATER TROCHANTER PROCEDURE THE SURGEON WAS SCREWING A RIM SCREW INTO THE ACETABULAR SHELL. THE TIP OF THE BIOMET SCREWDRIVER BROKE OFF IN THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE TIP BUT WAS UNABLE SO THE TIP WAS LEFT IN THE SCREW. THE PT HAD NO KNOWN COMPLICATION AND LEFT OPERATING ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SCREWDRVIER HXX BIOMET 424495 330210

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other