BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 16120616 · Received January 9, 2023

    Report

    Report Number
    1220246-2023-06062
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 22, 2022
    Report Date
    March 14, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED (B)(6) EASY-OUT COMPRESSION FT SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DEVICE HEX TIP WAS BROKEN OFF. THE FRAGMENTS GENERATED DURING THE EVENT WERE NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-62 EASY OUT TOOL BROKE WHILE REMOVING HARDWARE. CASE INVOLVEMENT, DEVICE BROKE DURING USE PER FACILITY: THREADED IN THE TOOL AND THE TIP BROKE INSIDE THE SCREW AND DID NOT CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574119 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1391931 00888867263833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown