BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 20630084 · Received November 7, 2024

    Report

    Report Number
    1220246-2024-08441
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 21, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE TIP OF THE ARTHREX ECLIPSE¿ HUMERAL HEAD EXTRACTOR HAD BROKEN OFF. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSES FOR THIS TYPE OF ISSUE/OCCURRENCE ARE PRYING/LEVERING THE DEVICE AGAINST OTHER INSTRUMENTATION DURING USE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 10/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9401-17 ARTHREX ECLIPSE¿ HUMERAL HEAD EXTRACTOR BROKE OFF. THIS OCCURRED DURING AN ECLIPSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE HEAD EXTRACTOR BROKE OFF WHEN REMOVING THE TRIAL HEAD AND THE FRAGMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625591 ECLIPSE HUMERAL HEAD EXTRACTOR MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 052145 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown