BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHREX GUIDE WIRE; 1.1MM AR 8737-41

    MDR report key: 12358863 · Received August 23, 2021

    Report

    Report Number
    MW5103420
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ANTHREX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE FRAGMENT BROKEN IN ANKLE DURING ORIF OF RIGHT ANKLE AND FOOT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251900 ANTHREX GUIDE WIRE; 1.1MM AR 8737-41 SCREW, FIXATION, BONE HWC ANTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR