BEUDAMED
    FDA Adverse Event Summary report: N

    ATHREX

    MDR report key: 3151814 · Received June 3, 2013

    Report

    Report Number
    MW5030452
    Date Received
    June 3, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ATHREX INC
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE IN THE (B)(6), THE PT WAS UNDERGOING A REPAIR OF HIS ANTERIOR CRUCIATE LIGAMENT FROM A TEAR IN HIS RIGHT KNEE. THE SURGEON WAS USING THE ARTHREX FLIPCUTTER, WHEN THE END OF THE FLIPCUTTER BROKE INSIDE THE RIGHT KNEE. THE SURGEON WAS REQUIRED TO RETRIEVE THE BROKEN DEVICE, INSIDE THE PT'S KNEE. THE SURGEON VERIFIED WITH X-RAY RESULTS, THAT THIS PIECE OF THE FLIPCUTTER WAS SUCCESSFULLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243138 ATHREX FLIPCUTTER II 10MM HRX ATHREX INC 308040263

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention