BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM

    MDR report key: 16341360 · Received February 9, 2023

    Report

    Report Number
    1220246-2023-06254
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    March 3, 2022
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867356733
    PMA / PMN Number
    K200341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION AND/OR PRYING/LEVERAGING DURING USE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT WHILE USING AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM AND AN AR-9301-51CPC ECLIPSE TRUNION, DURING THE FINAL STEPS, THE SURGEON DRILLED THE PILOT HOLE INTO THE SCREW AND FIXATION WAS COMPROMISED. SURGEON MOVED TO AN APEX SYSTEM INSTEAD. WHILE USING THE APEX, FIXATION WAS ALSO COMPROMISED WHEN TRAILING THE HEAD, SO SURGEON USED A LARGER SIZE INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169747 ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE MBI ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM 14635989 00888867356733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other