BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI MAXLOCK EXTREME K-WIRE 0.9MM

    MDR report key: 4239958 · Received November 3, 2014

    Report

    Report Number
    3005039508-2014-00013
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON WAS USING K-WIRE AND IT BROKE OFF IN THE BONE WHEN HE WENT TO PULL IT OUT. SURGEON FELT IT WOULD DO MORE DAMAGE TO ATTEMPT TO RETRIEVE IT THEREFORE HE LEFT IT IN THE PT'S BONE. ORIGINAL INTENDED PROCEDURE WAS REVISION OF OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT LDT METATARSAL OSTEOTOMY. DEVICE FAILED (BROKE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703873 MINI MAXLOCK EXTREME K-WIRE 0.9MM NONE HRS ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1