BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3943337 · Received June 17, 2014

    Report

    Report Number
    3943337
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SEGWAY ORTHOPAEDICS
    Product Code
    HTS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE SEGWAY RETROGRADE LIGAMENT KNIFE, THE END BROKE OFF INSIDE THE PATIENT'S RIGHT FOOT. USING A SCOPE AND FLOUROSCOPY, IT WAS DETERMINED THAT ALL PIECES WERE RETRIEVED FROM THE PATIENT'S FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355960 * KNIFE, ORTHOPEDIC HTS SEGWAY ORTHOPAEDICS 200-1003 1061401

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR