BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONX

    MDR report key: 273107 · Received April 10, 2000

    Report

    Report Number
    MW1018615
    Event Type
    Malfunction
    Date Received
    April 10, 2000
    Date of Event
    March 8, 2000
    Report Date
    March 27, 2000
    Manufacturer
    BIONX IMPLANTS, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ACL REPAIR THE SCREW BROKE IN HALF WHILE IMPLANTING IT INTO THE FEMUR. ATTEMPTS TO REMOVE THE SCREW WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX BIO-INTERFERENCE SCREW MAI BIONX IMPLANTS, INC. * 15914

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other