BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAUTILUS REAMER/DRILL GLOVE PROTECTOR

    MDR report key: 22783245 · Received August 12, 2025

    Report

    Report Number
    1220246-2025-03436
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867192638
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED AR-9216-4, LOT: 022412 REVEALED THAT THERE ARE STRIATION MARKS AND NICKS ALONG THE INNER DIAMETER OF THE DEVICE. ALSO, THE SLOT ALONG THE CANNULATION LENGTH IS BENT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO EXCESSIVE USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY ABRASION OCCURRED, SOME OF WHICH REMAINED STUCK TO THE PATIENT AND THE INSTRUMENT. NOTHING REMAINED IN THE PATIENT; IT WAS RINSED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. 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
    1889071 NAUTILUS REAMER/DRILL GLOVE PROTECTOR MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. NAUTILUS REAMER/DRILL GLOVE PROTECTOR 022412 00888867192638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown