BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BROACH HANDLE

    MDR report key: 2001398 · Received February 9, 2011

    Report

    Report Number
    2001398
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BIOMET, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE BROACH HANDLE ON THE PATIENT'S RIGHT HIP, THE HANDLE BROKE APART. SURGEON WAS ABLE TO RETRIEVE SCREW AND BOTH HANDLES. VISUAL INSPECTION OF SURGICAL SITE DID NOT REVEAL ANY PIECES. X-RAY WAS DONE TO ENSURE THAT NO FOREIGN BODIES WERE RETAINED. X-RAY WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BROACH HANDLE BROACH HANDLE HTQ BIOMET, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR