BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ORTHOPEDICS INC

    MDR report key: 484303 · Received September 18, 2003

    Report

    Report Number
    484303
    Event Type
    Malfunction
    Date Received
    September 18, 2003
    Date of Event
    August 9, 2003
    Report Date
    August 18, 2003
    Manufacturer
    BIOMET ORTHOPEDICS, INC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OR PROCEDURE TO REPAIR FRACTURE OF TIBIA AND RODDING OF RIGHT TIBIA-BALL TIP GUIDE ROD BROKE OFF WHILE SURGEON WAS REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS INC GUIDE PIN SET HTY BIOMET ORTHOPEDICS, INC REF-467265 530341

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other