BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 21190326 · Received January 20, 2025

    Report

    Report Number
    1220246-2025-00007
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298330
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    - ONE UNPACKAGED, AR-9618-24, 24 MM PRIMARY REAMER, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. - VISUAL EVALUATION NOTED THAT THE CUTTING BLADES WERE DULL AND NICKED. ADDITIONALLY, THE LASER MARKS WERE FADED. - THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE MANUFACTURING DATE IS 2018. - REFER TO INVESTIGATION PHOTOS. - COMPLAINT ALLEGATION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 6) OF AN AR-9618-24 PRIMARY REAMERS HAD GROWN DULL. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931163 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER 021814 00888867298330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown