BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 2482189 · Received March 5, 2012

    Report

    Report Number
    2482189
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 15, 2012
    Report Date
    March 5, 2012
    Manufacturer
    BIOMET
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    THE FLEXIBLE REAMER HEAD CAME APART FROM THE SHAFT. THE TIP BROKE OFF IN THE DISTAL FEMUR. THE FEMUR HAD TO BE EXPOSED AND THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMET FLEXIBLE INTRAMEDULLARY REAMER HTO BIOMET 468336 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR