BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS II REAMER, 8MM - HUDSON CONNECT

    MDR report key: 19373898 · Received May 22, 2024

    Report

    Report Number
    1220246-2024-03672
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    March 27, 2023
    Report Date
    May 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867058460
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-9202-28H SERIAL/BATCH NUMBER04512137 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH A MATTING PART T-HANDLE AR-9202-15H, BATCH 8001602, FOUND THAT THE DEVICE ATTACHED TO THE HANDLE WITHOUT ISSUES. UPON VISUAL EVALUATION, SCRATCHES ON THE HUDSON ADAPTER AND NICKS ON THE CUTTING BLADES WERE NOTED. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 4/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9202-28H UNIVERS II REAMER HAD AN ISSUE. THIS CANAL REAMER "DEVICE" WAS ATTACHED TO A REAMER "T-HANDLE" IN A NORMAL MANNER AND WOULD NOT LOCK ONTO THE T HANDLE. A SECOND T HANDLE WAS USED AND IT WOULD NOT LOCK ONTO THE DEVICE AS WELL. THE NEXT SIZE LARGER CALAR REAMER WAS USED TO COMPLETE THE SURGICAL PROCEDURE IN A STANDARD FASHION. NO ADDED TIME OR ADVERSE EVENT OCCURRED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 4/7/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A REVERSE TSA PROCEDURE ON (B)(6) 2023. NO PIECE OF THE INSTRUMENT BROKE WHILE IT WAS NOT LOCKING. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570154 UNIVERS II REAMER, 8MM - HUDSON CONNECT MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. UNIVERS II REAMER, 8MM - HUDSON CONNECT UNK 00888867058460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown