BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 23228187 · Received October 6, 2025

    Report

    Report Number
    1220246-2025-04474
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: B5, G3, H3, 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 CAN BE ATTRIBUTED TO MISUSE DUE TO PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 09/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO 3.9 SWIVELOCKS FROM THE AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM HAD BROKEN, WITH ONE BREAKING AFTER TAPPING. THE CASE WAS COMPLETED BY OPENING A REPLACEMENT KIT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/30/2025.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 10/06/2025: ON (B)(6) 2025, DURING A SUBSCAPULARIS REPAIR PROCEDURE, TWO 3.9 MM SWIVELOCKS COMPONENTS FROM THE AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM EXPERIENCED THREAD BREAKAGE DURING INSERTION. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM. THE BONE WAS PREPPED BY HALF TAPPING WITH A TAP IN THE SHOULDER TRAY, AND THE BONE QUALITY WAS ASSESSED AS GOOD. THERE WAS NO DELAY IN THE CASE, ALTHOUGH AN ADDITIONAL 5 TO 10 MINUTES OF ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264161 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15241133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown