BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 20461299 · Received October 16, 2024

    Report

    Report Number
    1220246-2024-08151
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 8, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676 ANGLED REAMER, DRIVE SHAFT LOT NUMBER: 022338 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED STRIATIONS ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE DEVICE. IT WAS FURTHER NOTED THAT THERE WERE NICKS AND DENTS ON THE SHAFT NEAR THE HUDSON-CONNECTION AREA. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO INSERT THE RETURNED AR-9676 ANGLED REAMER, DRIVE SHAFT INTO A KNOWN GOOD AR-9597-10 LOT NUMBER: 37622233. IT WAS NOTED THAT THE AR-9676 ANGLED REAMER, DRIVE SHAFT WAS MET WITH RESISTANCE AND FRICTION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    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 FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-9597-10, TWO (QTY.2) AR-9597-20, AND TWO (QTY.2) AR-9676 ANGLED REAMER INSTRUMENTS ARE STICKING. THEY OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582097 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT 022338 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown