BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 21136891 · Received January 13, 2025

    Report

    Report Number
    1220246-2025-09367
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 16, 2024
    Report Date
    July 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 12/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM DID NOT GET SUFFICIENT FIXATION WITH THE ECLIPSE TRUNION AND CAGE SCREW. THE CASE WAS COMPLETED USING A LONG STEM. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/30/2024: THE PART NUMBERS AR-9301-02 AND CAGE SCREW AND AR-9301-45CPC ARTHREX ECLIPSE TRUNION WERE PROVIDED. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER AND AN AR-9301-01 ARTHREX ECLIPSE CAGE SCREW WAS ATTEMPTED TO BE USED AS WELL BUT STILL COULD NOT GET SUFFICIENT FIXATION. THE CASE WAS COMPLETED USING AN AR-9100-05M UNIVERS APEX OPTIFIT HUMERAL STEM. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461037 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15345465 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown