BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAUTILUS REAMER/DRILL GLOVE PROTECTOR

    MDR report key: 19203705 · Received April 29, 2024

    Report

    Report Number
    1220246-2024-02568
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 5, 2024
    Report Date
    August 29, 2024
    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 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9216-4 /BATCH 022220, GLENOID REAMER/DRILL GLOVE PROTECTOR, WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION IT WAS NOTED THAT THERE ARE STRIATION MARKS AND NICKS ALONG THE INNER DIAMETER OF THE DEVICE. UPON INSPECTING UNDER A MAGNIFIER, THERE WERE SOME VISIBLE BLUE SHAVINGS NEAR THE SLOT ALONG THE CANNULATION LENGTH. 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 REVERSE SHOULDER SURGERY WHEN USING THE DEVICES AR-9216-4 (LOT: 022220) AND AR-9617 (LOT: 022225) IN COMBINATION DEBRIS WAS PRODUCED FROM THE AR-9216-4. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 08-APR-2024: IT WAS CONFIRMED THAT THE ERROR OCCURRED WHILE WORKING IN THE PATIENT, BUT NO DEBRIS FELL INTO THE PATIENT AND THEREFORE NOTHING HAD TO BE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980255 NAUTILUS REAMER/DRILL GLOVE PROTECTOR MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. NAUTILUS REAMER/DRILL GLOVE PROTECTOR 022220 00888867192638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown