BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MICRO COMPRESSION FT

    MDR report key: 11841670 · Received May 18, 2021

    Report

    Report Number
    1220246-2021-03098
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 29, 2021
    Report Date
    October 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263802
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8737-61, BATCH 1391932 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THREAD BREAKAGE AT THE DISTAL TIP OF THE DEVICE. THE FRAGMENT GENERATED DURING THE EVENT WAS NOT RETURNED FOR ANALYSIS. DUE TO THE RETURNED CONDITION OF THE DEVICE, THE GEOMETRY AT THE DISTAL TIP COULD NOT BE ACCURATELY ASSESSED. THE CAUSE REMAINS UNDETERMINED, ALTHOUGH A PROBABLE CAUSE CAN BE ATTRIBUTED TO USER APPLIED MECHANICAL FORCES DURING USE, SUCH AS THROUGH PRYING/LEVERAGING.

    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 THAT THE INSERTER TIP BROKE OFF DURING THE ANCHOR IMPLANT. THE SITE HAD BEEN PRE-DRILLED. THE TIP WAS RETRIEVED. THEY TRIED TO USE THE AR-8737-61 TO REMOVE THE ANCHOR, BUT THE METAL IN THE DEVICE STARTED TO SPLINTER. THE ANCHOR WAS REMOVED WITH PLIERS. AND THE ANCHOR WAS REMOVED WITH PLIERS. ANOTHER ANCHOR WAS USED TO COMPLETE THE BUNION CASE. PATIENT IS FEMALE, (B)(6) YEARS WITH HARD BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742530 EASY-OUT, MICRO COMPRESSION FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. EASY-OUT, MICRO COMPRESSION FT 1391932 00888867263802

    Patients

    Seq Age Sex Outcome Treatment
    1