BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM QUICK RELEASE DRILL

    MDR report key: 13697713 · Received March 8, 2022

    Report

    Report Number
    3025141-2022-00045
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED PRODUCT WAS INSPECTED UNDER MAGNIFICATION. UNDER MAGNIFICATION THE BATCH NUMBER OF THE 2.3MM QUICK RELEASE DRILL (PN 80-0627) WAS CONFIRMED AS 523641. THE TIP OF THE DRILL HAD BROKEN OFF; BOTH THE REMAINING SHAFT OF THE DRILL AND THE BROKEN TIP WERE RETURNED. THE FRACTURE SURFACE APPEARED VISUALLY NOT SMOOTH AND DID NOT SHOW FATIGUE LINES, WHICH IS INDICATIVE OF A SHEAR FORCE BREAK. THIS FRACTURE PATTERN IS A BRITTLE FRACTURE, INDICATING A SINGLE OVER-LOADING EVENT. THE OVERALL LENGTH OF THE RETURNED BROKEN TIP WAS MEASURED TO CONFIRM FRACTURE POINT AND APPROXIMATE HOW MUCH MATERIAL WAS GONE. THE DRILL MEASURED AT APPROXIMATELY 6.021 INCHES AND THE BROKEN TIP MEASURED APPROXIMATELY .986 INCHES, INDICATING THAT THE FRACTURE OCCURRED WITHIN THE FLUTE LENGTH OF THE DRILL. REVIEWING THE SURGICAL TECHNIQUE FOR THE ELBOW PLATING SYSTEM, THE 2.3MM QUICK RELEASE DRILL (80-0627) IS USED IN CONJUNCTION WITH THE 2.3 MM LOCKING DRILL GUIDE (80-0622) BY INSERTING THE DRILL THROUGH THE CENTER AND ADVANCING THE DRILL TO DESIRED DEPTH. NO DEFINITIVE CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, AS THE SURGEON WAS DRILLING, THE DEVICE SNAPPED CLEANLY. IT WAS NOT CLEAR WHETHER THE CAUSE WAS THE BONE BEING DENSE OR IMPACT WITH K WIRES. DUE TO THE USAGE OF TARGETING GUIDE, THE SURGEON FELT IT WASN'T TRAJECTORY. THE SURGERY WAS COMPLETED SMOOTHLY FOLLOWING THIS ISSUE, BUT THE SURGEON HAD TO TAKE TIME ENSURING THERE WAS NO METAL LEFT WITHIN THE PATIENT. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-00046 ON THE DRILL GUIDE USED IN THIS EVENT AND REPORT NUMBER 3025141-2022-00047 WHICH IS ON THE PLATE USED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760059 2.3MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0627 523641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown