BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE SPEEDSCAP IMPLANT SYSTEM

    MDR report key: 11872488 · Received May 24, 2021

    Report

    Report Number
    1220246-2021-03170
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO OF THE FIBERTAK ANCHORS WITHIN THE AR-9400-SBK SNAPPED WHEN PULLING THROUGH THE SUBSCAP. ANOTHER KIT WAS OPENED FOR TWO MORE ANCHORS AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770174 ECLIPSE SPEEDSCAP IMPLANT SYSTEM FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 12025498 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1