BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM PRIMARY REAMER

    MDR report key: 19962301 · Received August 12, 2024

    Report

    Report Number
    1220246-2024-07143
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, 24 MM PRIMARY REAMER, AR-9618-24, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE CUTTING BLADES ARE DULL, THE LASER MARKS ARE FADED AND THERE IS EVIDENCE OF CIRCUMFERENTIAL GRINDING ON THE DISTAL END OF THE SHAFT. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE MANUFACTURING DATE IS 2021.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9618-24 24 MM PRIMARY REAMER WAS WORN. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251944 24MM PRIMARY REAMER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 24MM PRIMARY REAMER 022102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown