BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENODESIS SCREW WITH HANDLED INSERTER

    MDR report key: 4080827 · Received September 4, 2014

    Report

    Report Number
    MW5038128
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ARTHREX
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 3X8 MM ARTHREX TENODESIS SCREW REF (B)(4), LOT #1143923, WAS BEING IMPLANTED BY ORTHOPEDIC SURGEON AND THE TIP OF THE SCREW DRIVER BROKE OFF IN PATIENT. BASED ON THE INFORMATION PROVIDED BY THE ARTHREX REPRESENTATIVE, SURGEON DECIDED TO INTENTIONALLY LEAVE THE TIP IN. REMOVAL WOULD CAUSE MORE DAMAGE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539522 TENODESIS SCREW WITH HANDLED INSERTER SCREWDRIVER HXX ARTHREX AR-1530PS 1143923

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other