BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTPRINT ULTRA - PK

    MDR report key: 2993085 · Received March 7, 2013

    Report

    Report Number
    1219602-2013-00061
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DELIVERY PORTION OF THE DEVICE WAS EVALUATED AND IT WAS CONFIRMED THAT THE TIP OF THE INNER DRIVER HAS BROKEN OFF. THE CAPA IS CURRENTLY ONGOING. (B)(4).

    Description of Event or Problem · 1

    AFTER THREE FOOTPRINT ANCHORS WERE FIXED, THE SURGEON FOUND THAT THE INNER SHAFT OF ONE INSERTER WAS BROKEN. SINCE THE INSIDES OF THE SITES WERE INVISIBLE BECAUSE OF BLOOD, SURGEON WAS UNABLE TO FIND THE BROKEN PIECE IN THE PATIENT VIA ARTHROSCOPY. AFTER THE SURGERY AN X-RAY WAS TAKEN AND THE SURGEON CONFIRMED THAT THE BROKEN TIP WAS INSIDE ONE OF THE ANCHORS. ACCORDING TO THE REPORT FROM THE SURGEON THEY USED THE DEVICE AS USUAL. THE SITE WAS PREPPED BY USING A STRAIGHT DISPOSABLE AWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96646 FOOTPRINT ULTRA - PK FOOTPRINT ULTRA PK SUT ANC, 4.5 MBI MANSFIELD MANUFACTURING SITE 72202901 50439536

    Patients

    Seq Age Sex Outcome Treatment
    1