BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 19382112 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03734
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    September 17, 2021
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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 IS CONTINUALLY APPLYING TORQUE WHEN THE IMPLANT IS SEATED AND /OR NOT ADVANCING.

    Description of Event or Problem · 0

    ON 09/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TOWARD THE END OF THE CASE, ONLY 3 OF THE 5 ANCHORS IN THE AR-9400-SBK SPEEDSCAP IMPLANT SYSTEM, WERE USED AS TWO SWIVEL LOCKS PULLED OUT. THE REMAINING ANCHORS WERE LEFT IN THE PATIENT AS THEY REMAINED WHOLE AND SECURE. THIS WAS DISCOVERED DURING A TOTAL SHOULDER ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING ARTHREX 4.75 SWIVEL LOCKS WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219882 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATION FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 12613993 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown