BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 18437325 · Received January 3, 2024

    Report

    Report Number
    1220246-2024-00046
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 4, 2023
    Report Date
    February 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. MANUFACTURED DATE 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE TIP OF THE SCREW REMOVER BROKE WHEN TRYING TO REMOVE A BROKEN SCREW. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME SCREW REMOVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 15-DEC-2023: THE BATCH NUMBER FOR THE AR-8737-62 WAS PROVIDED (1391942).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506764 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1391942 00888867263833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown