BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 15698293 · Received October 31, 2022

    Report

    Report Number
    1220246-2022-05675
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9401-17 ECLIPSE HUMERAL HEAD EXTRACTOR, BATCH NUMBER: 052202, WAS RECEIVED FOR INVESTIGATION. THE VISUAL EVALUATION CONFIRMS THE INSTRUMENT TIP HAD BROKEN OFF. ALSO, SIGNS OF WEAR AND DISCOLORATION SPOTS WERE OBSERVED ON THE INSTRUMENT. THE CAUSES REMAIN UNDETERMINED. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF INTERFERENCE BETWEEN THE DEVICE AND OTHER INSTRUMENTATION OR BONE DURING USE.

    Description of Event or Problem · 0

    ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9401-17 HUMERAL HEAD EXTRACTOR CHIPPED. THIS OCCURRED DURING AN ECLIPSE PROCEDURE WHILE REMOVING THE HUMERAL HEAD THE END OF IT CHIPPED. THE COMPONENT WAS REMOVED USING A STANDARD OSTEOTOME, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2952412 ECLIPSE HUMERAL HEAD EXTRACTOR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown