BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE DRILL, MINI CMP FT

    MDR report key: 23876589 · Received December 23, 2025

    Report

    Report Number
    1220246-2025-05768
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867127241
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED AR-8737-47 WITH BATCH 021834 NOTED THAT THE DISTAL TIP OF THE RETURNED DRILL HAD BROKEN OFF. THE BROKEN PIECES WERE NOT RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY TO TREAT A FRACTURE, THE DEVICE BROKE AND A PIECE OF IT BECAME LODGED IN THE PATIENT'S BONE. THIS WAS DISCOVERED DURING AN X-RAY EXAMINATION THE DAY AFTER THE OPERATION. THE BROKEN-OFF PIECE REMAINS PERMANENTLY INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800739 PROFILE DRILL, MINI CMP FT ARTHROSCOPIC ACCESSORIES NBH ARTHREX, INC. PROFILE DRILL, MINI CMP FT 021834 00888867127241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown