BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 20938075 · Received December 16, 2024

    Report

    Report Number
    1220246-2024-08858
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    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. ONE UNPACKAGED AR-9401-17 ARTHREX ECLIPSE¿ HUMERAL HEAD EXTRACTOR SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED BECAUSE THE DEVICE WAS RECEIVED DAMAGED FOR EVALUATION. A VISUAL EVALUATION REVEALED THAT THE CUTTING EDGE OF THE TIP HAD NICKS AND WAS BENT, DEFORMING THE GEOMETRY OF THE TIP. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS WEAR AND TEAR OVER REPETITIVE USE. THE INSTRUMENT MANUFACTURING DATE 2022.

    Description of Event or Problem · 0

    ON 11/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS(B)(4) THAT AN AR-9621-25T 25MM TAP BROKE WHILE TAPPING AND AN AR-9401-17 ECLIPSE HUMERAL HEAD EXTRACTOR TIP BROKE OFF / DISTORTED WHILE REMOVING THE TRIAL. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WITH NO PATIENT HARM. PIECE(S) BROKE OFF INSIDE OF THE PATIENT AND ALL BROKEN PIECES WERE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356013 ECLIPSE HUMERAL HEAD EXTRACTOR MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 052149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown