BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 16223347 · Received January 23, 2023

    Report

    Report Number
    1220246-2023-06149
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    January 4, 2023
    Report Date
    August 1, 2024
    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

    THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; 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 1/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING A SWIVELOCK FROM AN ECLIPSE SPEEDSCAP IMPLANT SYSTEM, IT BROKE. AN AR-2326BCC BIOCOMPOSITE SWIVELOCK WAS OPENED AND WHILE PASSING THE SUTURE THROUGH THE EYELET, IT SNAPPED OFF. ANOTHER AR-2326BCC BIOCOMPOSITE SWIVELOCK WAS OPENED, AND THE SAME THING HAPPENED, THE EYELET SNAPPED OFF WHILE PASSING THE SUTURE THROUGH IT. THIS WAS DISCOVERED DURING AN TSA PROCEDURE ON (B)(6) 2023. NEITHER ANCHOR WAS IMPLANTED, AS THIS WAS ALL OUTSIDE OF THE PATIENT, PRIOR TO IMPLANTATION. CASE WAS COMPLETED USING A 4.75 MM SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 1/5/2023: THE SWIVELOCK FROM THE ECLIPSE SPEEDSCAP IMPLANT SYSTEM, PART NUMBER AR-9400-SBK, HAD THE EYELET BREAK OFF INSIDE THE PATIENT DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING AR-2324BCC BIOCOMPOSITE SWIVELOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823316 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15014108 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown