BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 19202772 · Received April 29, 2024

    Report

    Report Number
    1220246-2024-02553
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    January 4, 2023
    Report Date
    April 29, 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

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 1/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE THREE FIBERTAKS FROM AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM, PULLED OUT OF IMPLANTATION SITE. THE CASE WAS COMPLETED SUCCESSFULLY USING THE SWIVELOCKS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/5/2023: THE SWIVELOCKS THAT WERE USED TO COMPLETE THE CASE WERE NOT PART OF THE KIT, BUT INSTEAD SURGEON USED INDIVIDUAL AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING A SHOULDER HEMI ARTHROPLASTY PROCEDURE. NOTHING BROKE INSIDE THE PATIENT AND ALL THE FIBERTAKS THAT PULLED OUT, WERE FULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000004 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 15014108 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown