BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE REAMER SHAFT, 2.0MM

    MDR report key: 12467672 · Received September 14, 2021

    Report

    Report Number
    1220246-2021-03650
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 14, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665023688
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT THE 0222-200 WAS FOUND DEFECTIVE AND UNUSABLE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION PROVIDED 8/27/2021: STARTED FLEX REAMER FROM AOS HUMERAL NAIL SET AT 6.5MM THROUGH A 10.5MM ENTRY HOLE DOWN THE HUMERAL CANAL. SURGEON IMMEDIATELY NOTICED A ¿CHATTER¿ SOUND WHICH THEN SIZED UP REAMERS BY .5MM UNTIL THEY REACHED 8. THROUGHOUT UPSIZED REAMING, SURGEON NOTICED THE SAME ¿CHATTER" SOUND. HALFWAY DOWN HUMERAL CANAL, FLEX REAMER BROKE AND REVEALED A FAULTY FLEX REAMER BASE WHICH HAD SEPARATED FROM THE FLEX SHAFT LEAVING AO CONNECT IN DRILL HAND PIECE. THE CASE WAS COMPLETED BY USING AN AOS TIBIA/FEMORAL FLEX REAMERS SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369349 FLEXIBLE REAMER SHAFT, 2.0MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. FLEXIBLE REAMER SHAFT, Ø2.0MM 00848665023688

    Patients

    Seq Age Sex Outcome Treatment
    1