BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCORKSCREW

    MDR report key: 819720 · Received February 5, 2007

    Report

    Report Number
    819720
    Event Type
    Malfunction
    Date Received
    February 5, 2007
    Date of Event
    January 26, 2006
    Report Date
    February 5, 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

    DURING OPEN SHOULDER SURGERY, THE SURGEON ATTEMPTED TO IMPLANT THE ARTHREX BIO CORKSCREW 5.5MM WITH #2 FIBERWIRE AND #2 TIGERWIRE. THE EYELET OF THE DEVICE PULLED THROUGH THE ANCHOR AND THE SURGEON WAS UNABLE TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCORKSCREW SUTURE ANCHOR, ORTHOPEDIC MBI ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 97334

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR