BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX FLIP CUTTER

    MDR report key: 7288372 · Received February 22, 2018

    Report

    Report Number
    7288372
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    November 1, 2017
    Report Date
    February 15, 2018
    Manufacturer
    ARTHREX INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. HERE FOR ACL REVISION WITH ALLOGRAFT. DURING PROCEDURE THE ANTHREX FLIPCUTTER SPLINTERED OFF INTO 4 FRAGMENTS INSIDE THE PT'S KNEE. ALL 4 FRAGMENTS WERE RECOVERED INTACT BY SURGEON DURING THE SURGERY WITH THE USE OF A C-ARM. NO ADVERSE PATIENT OUTCOME. MANUFACTURER RESPONSE FOR FLIP CUTTER, ARTHREX, INC. FLIP CUTTER (PER SITE REPORTER): NOT REPORTED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133881 ARTHREX FLIP CUTTER SURGICAL CUTTER GEI ARTHREX INC AR-1204AF-90 712373692

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR