BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 20158789 · Received September 6, 2024

    Report

    Report Number
    1220246-2024-07430
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Report Date
    June 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9676, BATCH 022338, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED SIGNS OF WEAR ON THE DEVICE: CIRCUMFERENTIAL GRINDING ON THE DISTAL AND PROXIMAL TIP. FUNCTIONAL TESTING WAS PERFORMED WITH A MATING PART AND IT WAS FOUND THAT THE REAMER CANNOT BE MOVED FREELY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT, AND AN AR-9597-10 ANGLED REAMER SLEEVE HAD AN ISSUE WHEN REAMING THE GLENOID. WHILE REAMING, THE SURGEON FELT THE REAMER "LOCK UP" ON HIM. THE SURGEON RETURNED THE INSTRUMENTATION TO THE TECH TO INSPECT, AND THE INNER SLEEVE WAS STUCK WITHIN THE OUTER SLEEVE OF THE ANGLED REAMER SHAFT. THIS ISSUE CAUSED THE ENTIRE DEVICE TO ROTATE AS ONE WHEN ON POWER AND PREVENTED THE REAMER FROM WORKING PROPERLY. PLIERS WERE USED TO DISASSOCIATE THE TWO PIECES FROM EACH OTHER. THEY REASSEMBLED IT AND MADE IT WORK TO PROCEED WITH THE CASE. DUE TO THE MALFUNCTION, THIS ISSUE ADDED 15-20 MINUTES TO THE CASE TIME. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140563 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown