BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTURATOR FOR AR-6550, AR-6567, AR-6570

    MDR report key: 18182304 · Received November 21, 2023

    Report

    Report Number
    1220246-2023-08837
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 25, 2023
    Report Date
    August 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867402768
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 -ONE UNPACKAGED AR-6549Q OBTURATOR LOT: 0072220 WAS RECEIVED FOR INVESTIGATION. -VISUAL EVALUATION NOTED NO PROBLEMS WITH THE DEVICE. -FUNCTIONAL TESTING WAS PERFORMED BY INSERTING THE AR-6549Q OBTURATOR INTO AN AR-6550 TWIST-IN CANNULA AND IT WAS FOUND THAT THE OBTURATOR WAS ABLE TO BE COMPLETELY INSERTED AND WOULD SIT FLUSH AGAINST THE TWIST-IN CANNULA. -NO PROBLEM FOUND. -REFER TO INVESTIGATION PHOTOS. -COMPLAINT ALLEGATION IS NOT CONFIRMED.

    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 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6549Q OBTURATOR WOULD NOT FIT DOWN THE COMMUTATION OF 7X7 CANNULA AND WOULD STOP AROUND 2/3 WAY DOWN. THE DEVICE WAS TRIED ON SEVERAL CANNULAS. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW DEVICE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854791 OBTURATOR FOR AR-6550, AR-6567, AR-6570 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. OBTURATOR FOR AR-6550, AR-6567, AR-6570 UNK 00888867402768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown