BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA W/ OBLIQUE WINDOW:11 X 134MM

    MDR report key: 19657693 · Received July 2, 2024

    Report

    Report Number
    1220246-2024-06552
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 4, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867427860
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-S3420-110-134 CANNULA, W/ OBLIQUE WINDOW WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE NOTED DAMAGED TO THE DIAMETER OF THE DEVICE, IT WAS BENT AND SLIGHTLY WARPED. FUNCTIONAL TESTING WAS CONDUCTED BY ATTEMPTING TO PASS THE RETURNED DEVICE THROUGH AN AR-S3350-1015-139 SPINE ENDOSCOPE AND IT WAS NOTED THAT THE ENDOSCOPE COULD NOT PASS OR FIT THROUGH THE CANNULA. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE. REFER TO INVESTIGATION PHOTOS.

    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.

    Description of Event or Problem · 0

    ON 06/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-S3420-110-134 DIDN'T PASS OR FIT THROUGH THE CANNULA. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601961 CANNULA W/ OBLIQUE WINDOW:11 X 134MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. CANNULA W/ OBLIQUE WINDOW:11 X 134MM UNK 00888867427860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown