BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 1190230 · Received October 7, 2008

    Report

    Report Number
    MW5008568
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 29, 2008
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIO PUSHLOCK ANCHOR BROKE WHILE SURGEON WAS TRYING TO PUT THE ANCHOR TO THE PT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX BIO-PUSH LOCK MAI 207740

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other