BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CORKSCREW

    MDR report key: 879009 · Received June 22, 2007

    Report

    Report Number
    879009
    Event Type
    Malfunction
    Date Received
    June 22, 2007
    Report Date
    June 22, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHEN INSERTING THE ANCHOR INTO THE PATELLA THE TIP OF THE ANCHOR BROKE OFF. ALL THE BROKEN PIECES WERE RETRIEVED. THE PROCEDURE CONTINUED AND NO FURTHER PROBLEMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SURGICAL HARDWARE, ANCHOR MBI ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 110192

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR