BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 19528036 · Received June 13, 2024

    Report

    Report Number
    1220246-2024-05671
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    April 30, 2021
    Report Date
    June 13, 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 COMPLAINT ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR, IMPROPER BONE PREPARATION, MISALIGNED INSERTION, OR EXCESSIVE FORCES THROUGH LEVERAGING/PRYING THE DEVICE. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE AND THE BONE QUALITY ENCOUNTERED WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIVE ANCHORS FROM THE AR-9400-SBK SUBSCAP SYSTEM WOULD NOT SEAT; THEY EACH PULLED OUT. THEY USED A SPEEDBRIDGE TO COMPLETE THE CASE. THE SAME SITE WAS USED; THERE WERE NO ADDITIONAL INCISIONS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124704 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 12025498 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown