BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CORKSCREW

    MDR report key: 823622 · Received February 19, 2007

    Report

    Report Number
    823622
    Event Type
    Malfunction
    Date Received
    February 19, 2007
    Date of Event
    February 16, 2007
    Report Date
    February 19, 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

    THE PATIENT WAS DIAGNOSED WITH A TEAR OF THE RIGHT ROTATOR CUFF. WHILE ATTEMPTING TO IMPLANT THE BIO-CORKSCREW FOR ROTATOR CUFF REPAIR, A PLASTIC PIECE OF THE IMPLANT BROKE OFF IN THE BONE. THE REMAINING PIECE WAS REMOVED. THERE WAS NO APPARENT HARM TO THE PATIENT. AN ADDITIONAL FIVE BIO-CORKSCREWS WERE IMPLANTED WITHOUT INCIDENT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SURGICAL HARDWARE, SUTURE ANCHOR MBI ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 97327

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR