BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 18162135 · Received November 17, 2023

    Report

    Report Number
    1220246-2023-08787
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 24, 2023
    Report Date
    January 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. COMPLAINT IS CONFIRMED. VISUAL EVALUATION NOTED AR-9676 HAD NICKS AT THE DISTAL END OF THE SHAFT. FUNCTIONAL TESTING NOT PERFORMED DUE TO THE DEVICES AR-9676 AND AR-9597-10 ARE STUCK. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    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 10/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE STARTED BIDING UP AND GOT STUCK TOGETHER ALONG WITH AN AR-9676 ANGLED REAMER, DRIVER SHAFT, AND AN AR-9241-03 GLENOID INSERTER/IMPACTOR HAD A PIECE OF THE BLUE PLASTIC BREAK DURING THE CASE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY BY USING THE SAME PRODUCTS AGAIN BY OPENING A NEW TRAY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 10/27/2023: THIS WAS DISCOVERED DURING A REVERSE SHOULDER PROCEDURE ON (B)(6) 2023. THERE WAS A DELAY OF A COUPLE OF MINUTES TO OPEN ANOTHER TRAY WITH NO ADDITIONAL ANESTHESIA ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986584 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT UNK 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown