BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CORKSCREW

    MDR report key: 2042374 · Received March 30, 2011

    Report

    Report Number
    2042374
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ARTHREX
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    BROKEN DISPOSABLE ANCHOR DURING SHOULDER SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW ANCHOR, FIXATION, BONE HWC ARTHREX * 353370

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR