BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 856827 · Received May 15, 2007

    Report

    Report Number
    856827
    Event Type
    Malfunction
    Date Received
    May 15, 2007
    Date of Event
    May 7, 2007
    Report Date
    May 15, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    AS THE SURGEON WAS INSERTING THE 3.5MM BIO PUSHLOCK DEVICE TO THE PATIENT'S RIGHT SHOULDER, THE DEVICE BROKE INTO SEVERAL PIECES. THE PIECES WERE RETRIEVED BY THE SURGEON VIA SCOPE. THE SURGEON BELIEVES HE RETRIEVED ALL THE BROKEN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL HARDWARE, ANCHOR, PUSHLOCK MAI ARTHREX ARTHROSCOPY INSTRUMENTS, INC * 122979

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR