BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOOTH K-WIRE

    MDR report key: 6614003 · Received June 6, 2017

    Report

    Report Number
    6614003
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 15, 2017
    Report Date
    May 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    K-WIRE BROKE DURING ORTHO REPAIR OF LIZ FRANC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396121 SMOOTH K-WIRE PIN, FIXATION, SMOOTH HTY BIOMET ORTHOPEDICS, LLC 1650-22-000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR