BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HUMERAL HEAD EXTRACTOR

    MDR report key: 22998588 · Received September 8, 2025

    Report

    Report Number
    1220246-2025-03751
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867060333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-9401-17, ECLIPSE HUMERAL HEAD EXTRACTOR, BATCH NUMBER 052450, WAS RECEIVED FOR INVESTIGATION AND THE VISUAL INSPECTION REVEALED THAT THE CUTTING EDGE OF THE TIP HAD NICKS AND WAS BENT, DEFORMING THE GEOMETRY OF THE TIP (SEE EVALUATION PICTURES 3 + 4). NO FRAGMENTS WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSES FOR THIS TYPE OF ISSUE/OCCURRENCE ARE PRYING/LEVERING THE DEVICE AGAINST OTHER INSTRUMENTATION DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVISION SURGERY OF A SHOULDER PROSTHESIS; IT WAS NOT POSSIBLE TO USE THE AR-9401-17 IN THE NOTCHES AS USUAL. INSTEAD, THE IMPLANT HAD TO BE BROKEN UP AND THE EXTRACTION INSTRUMENT BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. IN ADDITION, AR-9545-T15-02 WAS WORN OUT ON ARRIVAL. THE DEVICE COULD BE USED DURING SURGERY BUT SHOULD NOT BE USED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407482 ECLIPSE HUMERAL HEAD EXTRACTOR MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR 052450 00888867060333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown