BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVL ANGLED REAMER SLEEVE ASSEMBLY, 25

    MDR report key: 18953472 · Received March 21, 2024

    Report

    Report Number
    1220246-2024-01621
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 29, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867350045
    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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9297-25 / BATCH 052224 WAS RECEIVED FOR INVESTIGATION. THE REAMER AR-9676 WAS RECEIVED STUCK INSIDE. THE SHOULDER OF THE AR-9676 IS SITTING FLUSH AGAINST THE SLEEVE. BECAUSE THE DEVICES WERE STUCK, IT WAS NOT POSSIBLE TO MEASURE THE ID OF THE SLEEVE OR OD OF THE REAMER. 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 ()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
    891872 AVL ANGLED REAMER SLEEVE ASSEMBLY, 25 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 25 052224 00888867350045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown