BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 1668695 · Received April 22, 2010

    Report

    Report Number
    MW5015682
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 22, 2010
    Manufacturer
    BIOMET
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REMOVE BIOMET HARDWARE FROM LEFT FEMUR, THE BIOMET INSTRUMENT USED TO REMOVE THE NAIL BROKE. THERE WAS NO OTHER WAY TO REMOVE IT. A DIFFERENT INSTRUMENT DESIGNED ONLY TO REMOVE THAT NAIL WILL BE SHIPPED TO US TONIGHT AND THE SURGERY WILL BE COMPLETED TOMORROW. BIOMET ACKNOWLEDGED THAT THIS INSTRUMENT HAS FAILED TO FUNCTION PROPERLY BEFORE, THAT IS WHY THE NEW INSTRUMENT WAS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMET INSTRUMENT LXH BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR