BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM QUICK RELEASE DRILL

    MDR report key: 14341556 · Received May 9, 2022

    Report

    Report Number
    3025141-2022-00132
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 6, 2022
    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 DRILL WAS INSPECTED UNDER MAGNIFICATION. THE BATCH NUMBER OF 2.8MM QUICK RELEASE DRILL (PN 80-0387) WAS CONFIRMED AS 445671. UNDER MAGNIFICATION, THE ENTIRE SHAFT OF THE DRILL SHOWED NO SIGNS OF SIGNIFICANT WEAR. THE TIP OF THE DRILL HAD BROKEN OFF, AND THE BROKEN PORTION OF THE TIP WAS NOT RETURNED. THE OVERALL LENGTH OF THE DRILL WAS MEASURED TO CONFIRM FRACTURE POINT AND APPROXIMATE HOW MUCH MATERIAL HAD BROKEN OFF THE DRILL TIP. THE RETURNED DRILL MEASURED 6.1175 INCHES INDICATING THAT APPROXIMATELY 0.8825 INCHES HAD BROKEN OFF THE DRILL AND WAS NOT RETURNED. THE FRACTURE SURFACE WAS NEARLY STRAIGHT ACROSS THE DRILL, PERPENDICULAR TO THE LONG AXIS OF THE DRILL SHAFT. THE FRACTURE SURFACE APPEARED BRITTLE AND GRITTY IN APPEARANCE INDICATING A SHEAR FRACTURE FROM A SINGLE HIGH-ENERGY EVENT. DUE TO UNKNOWN PROCEDURAL CONDITIONS, NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE DRILL BROKE WHEN DRILLING THE DISTAL TIBIA. THE BROKEN PIECE OF THE DRILL STILL REMAINS IN THE PATIENT'S BONE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534256 2.8MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0387 445671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown