BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS HUMERAL CUP REAMER -M/39

    MDR report key: 19476083 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05033
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    September 30, 2022
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867061552
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9508-39 SERIAL/BATCH NUMBER AR07770301 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TEST WITH AR-9510RG-R, BATCH# 051549, FOUND THAT THE DEVICE AND THE MATTING WORK AS REQUIRED. VISUAL EVALUATION FOUND HEAVY LINES INSIDE THE DIAMETER OF THE HUMERAL CUP, AS WELL AS MANY BURRS WERE OBSERVED ON THE HOLES OF THE CUP. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCES APPLIED DURING USE.

    Description of Event or Problem · 0

    ON 09/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE SURGEON HAD DIFFICULTY INSERTING THE AR-9508-39 REAMER OVER THE 135 +2 RIGHT REAMER GUIDE PIN. WHEN USING THE REAMER ON POWER, IT APPEARED TO CATCH AND TORQUE ON THE GUIDE PIN. A NEW TRAY WAS OPENED AND ANOTHER AR-9508-39 WAS USED TO COMPLETE THE CASE. POST-SURGERY INSPECTION APPEARS TO SHOW SOME WEAR MARKS ON THE INTERNAL PORTION OF THE 39MM REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8115 UNIVERS REVERS HUMERAL CUP REAMER -M/39 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVERS HUMERAL CUP REAMER -M/39 AR07770301 00888867061552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown