BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX FLEXIBLE REAMER WITH FLEXIBLE TIGHTROPE DRILL PIN

    MDR report key: 14999626 · Received July 13, 2022

    Report

    Report Number
    14999626
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 29, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE FROM STAFF: A DISPOSABLE REAMER BROKE, DURING SURGERY, IN THE PATIENT'S LEFT KNEE. SURGERY WAS STOPPED. THE REAMER WAS REMOVED FROM THE KNEE. SURGERY PROCEEDED. NARRATIVE FROM OPERATIVE REPORT: A FLEXIBLE GUIDE PIN FROM THE ARTHREX FLEXIBLE REAMER SYSTEM WAS PASSED THROUGH THE CENTER POINT OF THE PREVIOUSLY PLACED SOCKET AND TUNNEL. THIS TOOK A SIGNIFICANT PORTION OF TIME TO APPROPRIATELY STRATEGIZE TRAJECTORY. ONCE WE WERE SATISFIED WITH THIS, WE BROUGHT IN THE FLEXIBLE REAMER; HOWEVER, IMMEDIATELY UPON INITIATION OF REAMING, THE REAMER BROKE, AND THE FLEXIBLE REAMER WAS REMOVED ENTIRELY WITHOUT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773141 ARTHREX FLEXIBLE REAMER WITH FLEXIBLE TIGHTROPE DRILL PIN BIT, SURGICAL GFG ARTHREX, INC. 18F20

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA Female