BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE CENTERING DEVICE

    MDR report key: 18691492 · Received February 12, 2024

    Report

    Report Number
    1220246-2024-00922
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 26, 2024
    Report Date
    May 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS DAMAGE TO THE DEVICE DUE TO MISUSE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS RECEIVED.

    Description of Event or Problem · 0

    ON 1/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9401-09 ARTHREX ECLIPSE CENTERING DEVICE GOT STUCK AND BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT, WITH NO BROKEN PIECES LEFT IN THE PATIENT. THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY, WITH NO ADVERSE EVENT OR PATIENT HARM REPORTED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765703 ECLIPSE CENTERING DEVICE MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. ECLIPSE CENTERING DEVICE 05921402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown