BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 14744658 · Received June 20, 2022

    Report

    Report Number
    1220246-2022-05118
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    June 3, 2022
    Report Date
    November 17, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    VISUAL INSPECTION FOUND THE DEVICE BROKE AT THE DISTAL TIP OF THE DEVICE. COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    ON 06/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9401-17 ECLIPSE¿ HUMERAL HEAD EXTRACTOR BROKE IN AN UNSPECIFIED PROCEDURE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 06/20/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2022, NO ATTACHMENT WAS USED WITH THE DEVICE. A PIECE BROKE INSIDE THE PATIENT, AND THE PIECE WAS RETRIEVED. AN OSTEOTOME HAD TO BE USED AS A REPLACEMENT, THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS FINE TO DATE. THE COMPLAINT DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267202 ECLIPSE HUMERAL HEAD EXTRACTOR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 250090803 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown