BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM QUICK RELEASE DRILL

    MDR report key: 21357485 · Received February 11, 2025

    Report

    Report Number
    3025141-2025-00060
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 11, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. HOWEVER, THE REPORTED 1.5MM HEX DRIVER TIP, LOCKING GROOVE (PART NUMBER 80-0728, BATCH NUMBER 599700), 2.8MM X 5" QUICK RELEASE DRILL (PART NUMBER MS-DC28, BATCH NUMBER 447604), AND 2.8MM QUICK RELEASE DRILL (PART NUMBER 80-0387, BATCH NUMBER 594442) WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE REPORTED SCREW WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS THE MODEL NUMBER AND BATCH/LOT NUMBER OF THE SCREW IS UNKNOWN.

    Description of Event or Problem · 0

    (REPORT 4 OF 4) IT WAS REPORTED DURING SURGERY WHILE THE SURGEON WAS INSERTING THE LOCKING SCREW THE DRIVER TIP BROKE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE AND THEREFORE IT WAS NOT LEFT IN THE PATIENT'S BODY. IT WAS ALSO REPORTED THE DRILL PENETRATED BONE AND SOFT TISSUE WHILE DRILLING WAS PERFORMED. THE DRILLS CONTACTED THE OPERATING TABLE RESULTING IN ONE DRILL BENDING AND ANOTHER BREAKING. THE SURGERY WAS COMPLETED WITH REPLACEMENT DEVICES AFTER A 10-MINUTE DELAY. NO OTHER PATIENT CONSEQUENCES WERE REPORTED. THERE ARE 4 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2025-00057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966269 2.8MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0387 594442

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female