BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QUICK RELEASE DRILL

    MDR report key: 17926451 · Received October 12, 2023

    Report

    Report Number
    3025141-2023-00538
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 12, 2023
    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. THE 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 559873) WAS RETURNED FOR EVALUATION. THE RETURNED DRILL WAS EXAMINED UNDER MAGNIFICATION. AN APPROXIMATELY 0.8450" SECTION OF THE DRILL TIP SNAPPED OFF FROM USE IN SURGERY. THE FLUTES ARE MISSHAPEN, AS THE CHANNELS ARE CLEARLY DEFORMED UNTIL THE FLUTING TRANSITIONED TO THE NON-CUTTING SECTION OF THE DRILL SHAFT. NO OTHER SIGNIFICANT SIGNS OF WEAR OR DAMAGE WERE OBSERVED. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SURGERY, THE SURGEON WAS DRILLING BY THE PATIENT'S DISTAL RADIUS WITH A 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 559873), WHEN THE TIP BROKE. IT WAS ALSO REPORTED THAT THE SURGEON RETRIEVED THE BROKEN PIECE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE SURGERY WITH NO DELAYS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415435 2.0MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0318 559873

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown