BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 18430178 · Received January 2, 2024

    Report

    Report Number
    1220246-2024-00016
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 4, 2023
    Report Date
    February 18, 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 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 IN THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE TIP OF THE DEVICE BROKE WHEN TRYING TO REMOVE A BROKEN SCREW FROM THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Description of Event or Problem · 0

    UPDATE AVOE 06-DEC-2023: IT WAS FURTHER REPORTED THAT WHEN THE SCREW BROKE, IT STILL PROTRUDED APPROX. 1 CM FROM THE BONE AT A LENGTH OF 44 MM. UPDATE AVOE 12-JAN-2024: IT WAS FURTHER CONFIRMED THAT THE SCREW COULD NOT BE REMOVED FROM THE PATIENT AFTER THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680950 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1391937 00888867263833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown