BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID CORING REAMER, SMALL

    MDR report key: 19565867 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06054
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 13, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867057630
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9127-01 /BATCH 04511802, CORING REAMER, WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION IT WAS NOTED THAT THE WHITE CAP (ALIGNMENT TIP) IS MISSING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE. THE MANUFACTURING DATE IS JANUARY 2018.

    Description of Event or Problem · 0

    ON 5/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9127-01 ARTHREX UNIVERSAL GLENOID CORING REAMER WAS MISSING THE WHITE-CENTERED KNOB AND WAS DISCOVERED DURING THE CASE. THE CASE WAS COMPLETED BY UNTHREADING ONE FROM THE MEDIAL REAMER AND PUTTING IT ON THE SMALL REAMER TO FINISH THE CASE AND NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/29/2024: THERE WAS NO CASE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673561 UNIVERSAL GLENOID CORING REAMER, SMALL ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERSAL GLENOID CORING REAMER, SMALL UNK 00888867057630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown