BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM

    MDR report key: 18139859 · Received November 15, 2023

    Report

    Report Number
    3008864603-2023-00001
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Manufacturer
    AVALIGN TECHNOLOGIES, INC.
    Product Code
    HTW
    UDI-DI
    00190776118211
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DEVICE HAS NOT BEEN RETURNED TO AVALIGN TECHNOLOGIES AS OF 24 OCT 2023. BASED ON THE PHOTOS PROVIDED WITH THE COMPLAINT, THE DEFECT WAS ABLE TO BE CONFIRMED. AS THE COMPLAINT PHOTO ONLY INCLUDED THE BROKEN TIP OF THE DRILL BIT, NOTHING COULD BE DETERMINED REGARDING THE USE OF THIS DEVICE. COMPLAINT PRODUCT WAS FROM LOT 111419. THERE WERE 2 POTENTIAL SHIPMENTS IDENTIFIED FOR THE COMPLAINT DEVICE: INVOICE #(B)(4) WAS SHIPPED ON 11/10/2022 (1 UNIT) . INVOICE #(B)(4) WAS SHIPPED ON 1/18/2023 (6 UNITS). REVIEW OF NCMR AND COMPLAINT DATA FOR 85-1511023 WAS COMPLETED ON 18 OCT 2023. DURING THE REVIEW 0 COMPLAINTS OR NCMRS WERE IDENTIFIED. DHR REVIEW FOR LOT 111419 DETERMINED THAT ALL MANUFACTURING RECORDS WERE CORRECT AND COMPLETE. NO DISCREPANCIES WERE IDENTIFIED WHICH WOULD HAVE RESULTED IN THE ABOVE COMPLAINT RECORD.

    Description of Event or Problem · 0

    DURING A RIGHT TOTAL KNEE ARTHROPLASTY, APPROXIMATELY 1 CM OF THE TIP OF THE DRILL BIT (MILLENNIUM 85-1511023 1.5MM) WAS RETAINED IN THE DISTAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320775 MILLENNIUM DRILL BIT HTW AVALIGN TECHNOLOGIES, INC. 85-1511023 111419 00190776118211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown