BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 18271068 · Received December 5, 2023

    Report

    Report Number
    1220246-2023-09188
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 7, 2023
    Report Date
    January 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT CANNOT BE CONFIRMED BECAUSE THE DEVICE CANNOT BE VISUALLY AND FUNCTIONALLY EVALUATED. 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(S) FOR THE REPORTED FAILURE CAN BE A USER ERROR DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 11/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM HAD AN ISSUE. THE 3.9 MM SWIVELOCK INSERTER BENT UPON INSERTION. THE INSERTER DID NOT BREAK, BUT THE SCREW WAS UNUSABLE. THE CASE WAS COMPLETED USING ANOTHER AR-9400-SBK FROM A DIFFERENT LOT WITH A DELAY OF A MINUTE AND NO FRAGMENTS LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TOTAL SHOULDER JOINT REPAIR PROCEDURE ON (B)(6) 2023, WITH NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160140 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15103665 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown