BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADED REAMER 6MM, CANNULATED

    MDR report key: 19750651 · Received July 16, 2024

    Report

    Report Number
    1220246-2024-06769
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867016620
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AR-1406 CANNULATED HEADED REAMER, 6 MM LOT NUMBER: 022232 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED WEAR AND TEAR ON THE DEVICE WITH SLIGHTLY FADED LASER MARKINGS AND DISCOLORATION OBSERVED THROUGHOUT THE DEVICE. IT WAS FURTHER NOTED THAT THERE WAS DAMAGE TO THE TIP OF THE DEVICE WITH SCRATCHES OBSERVED ON THE FLUTE AREA OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USE. MANUFACTURED DATE: 26-AUG-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL IS DULL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508111 HEADED REAMER 6MM, CANNULATED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. HEADED REAMER 6MM, CANNULATED 022232 00888867016620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown