BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QUICK RELEASE DRILL

    MDR report key: 16915490 · Received May 11, 2023

    Report

    Report Number
    3025141-2023-00302
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 9, 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 RETURNED 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 492449) WAS EXAMINED UNDER MAGNIFICATION. THE LENGTH WAS MEASURED TO BE 5.7265 INCHES INDICATING THAT APPROXIMATELY 0.0235 INCHES WAS BROKEN OFF OF THE TIP. THE FRACTURE SURFACE INDICATED A BRITTLE FRACTURE, AND THE DRILL TIP FRAGMENT(S) WERE NOT RETURNED. NO OTHER DAMAGE WAS IDENTIFIED ALONG THE RETURNED DEVICE, AND MINIMAL WEAR WAS SHOWN ALONG THE EDGES OF THE DRILL TIP. POSSIBLE REASONS FOR THIS TO OCCUR INCLUDE EXCESSIVE SIDE LOAD DURING DRILLING OR ENCOUNTERING DENSE OR HARD BONE. HOWEVER, BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NURSE FOUND AFTER SURGERY THAT THE TIP OF THE DRILL "WAS LACKING". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. IT WAS ALSO STATED IT WAS BELIEVED THE PHYSICIAN WAS UNAWARE OF THE DAMAGE TO THE DRILL AND CONTINUED TO USE THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842463 2.0MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0318 492449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown