BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 19398240 · Received May 25, 2024

    Report

    Report Number
    1220246-2024-03932
    Event Type
    Malfunction
    Date Received
    May 25, 2024
    Date of Event
    February 18, 2022
    Report Date
    May 25, 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
    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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 02/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9400-SBK IMPLANT SYSTEM ANCHOR WOULD NOT SEAT AND EVERY SINGLE ONE PULLED OUT OF IMPLANTATION SITE. SURGEON COMPLETED CASE USING A LARGER SWIVELOCK. NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ECLIPSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677079 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 12614086 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown