BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 18897318 · Received March 13, 2024

    Report

    Report Number
    1220246-2024-01457
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 29, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

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

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. -ONE UNPACKAGED AR-9676 / BATCH 022304 WAS RECEIVED FOR INVESTIGATION. THE REAMER AR-9676 WAS RECEIVED STUCK INSIDE AN AR-9297-25 / BATCH 052224. -THE SHOULDER OF THE AR-9676 IS SITTING FLUSH AGAINST THE SLEEVE. BECAUSE THE DEVICES WERE STUCK, NO FUNCTIONAL TESTING WAS POSSIBLE. -VISUAL EVALUATION FOUND MULTIPLE DENTS AND SCRATCHES AROUND THE SHAFT AND IN THE COLLAR SLEEVE. -THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF OVERHEATING DURING USE CAUSED BY OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.

    Description of Event or Problem · 0

    ON 02/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9297-25 AVL ANGLED REAMER SLEEVE ASSEMBLY, 25 AND AN AR-9676 ANGLED REAMER DRIVE SHAFT COLD WELDED AND WOULD NOT COME APART OUT OF THE AUGMENTED VAULTLOCK GLENOID INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184819 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022304 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown