BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CORKSCREW SUTURE ANCHOR

    MDR report key: 823630 · Received January 31, 2007

    Report

    Report Number
    823630
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    January 22, 2007
    Report Date
    January 31, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE BIO-CORKSCREW ANCHOR BROKE INSIDE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SUTURE ANCHOR HARDWARE, ORTHOPEDIC MBI ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * 41517

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR