BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE RESECT PROTECTOR,SZ S/40.0MM

    MDR report key: 20343707 · Received October 1, 2024

    Report

    Report Number
    1220246-2024-07907
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 23, 2024
    Report Date
    July 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867060364
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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: G3, H3, H6 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 IS WEAR AND TEAR INCURRED OVER REPEATED USE.

    Description of Event or Problem · 0

    ON 09/23/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 4) OF AN AR-9401-40 ARTHREX ECLIPSE RESECTION PROTECTOR, SIZE S / 40 MM, WAS STRIPPING AWAY. THIS WAS DISCOVERED DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 09/26/2024: THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. THE DEVICE DID NOT BREAK, AND NO DEBRIS WAS PRODUCED. THERE WAS NO CASE DELAY. THE CASE WAS COMPLETED SUCCESSFULLY, AND THE DEVICES WERE NOT NEEDED ANYMORE AFTER THE ISSUE WAS NOTICED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41933 ECLIPSE RESECT PROTECTOR,SZ S/40.0MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ S/40.0MM UNK 00888867060364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown