BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 23154026 · Received September 26, 2025

    Report

    Report Number
    1220246-2025-04148
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 7, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 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 MISUSE DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 9/9/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO FIBERTAK ANCHORS FROM AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM PULLED OUT DURING DEPLOYMENT. ATTEMPTS TO REDEPLOY THE ANCHORS WERE UNSUCCESSFUL. ALL IMPLANTS WERE RETRIEVED, AND NO PATIENT HARM OCCURRED. ALTERNATIVE HARD BODY ANCHORS WERE SUCCESSFULLY USED IN THEIR PLACE, AND THE REPAIR WAS COMPLETED WITHOUT ISSUE. THIS WAS DISCOVERED SUBSCAPULARIS REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 09/22/2025: TWO FIBERTAK ANCHORS FROM AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM PULLED OUT DURING THE PROCEDURE; HOWEVER, NO PIECES BROKE OFF. BOTH ANCHORS WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING AN AR-1927PSF-45 PEEK CORKSCREW FT SUTURE ANCHOR. THE PROCEDURE WAS DELAYED BY TWO MINUTES, WITH AN ADDITIONAL TWO MINUTES OF ANESTHESIA ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935272 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15281759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown