BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QR DRILL, W/ DEPTH MARKS

    MDR report key: 17542181 · Received August 14, 2023

    Report

    Report Number
    3025141-2023-00407
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 14, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED 2.0MM QR DRILL, W/ DEPTH MARKS (PART NUMBER 80-2378, BATCH 559525) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE DRILL (PART NUMBER 80-2378, BATCH 559525) LENGTH WAS MEASURED TO CONFIRM FRACTURE POINT AND APPROXIMATE HOW MUCH MATERIAL WAS GONE. UNDER CLOSE INSPECTION VISUALLY THE FRACTURE SURFACE IS NOT AS SMOOTH AND DOES NOT SHOW FATIGUE LINES, WHICH IS INDICATIVE OF A SHEAR FORCE BREAK. THE FRACTURE SURFACE IS NEARLY TRANSVERSE TO THE LONG AXIS OF THE DRILL. THE ORIGINAL SPECIFIED LENGTH, PER PRINT, OF THE DRILL IS 5.80 AND THE OVERALL LENGTH AFTER FRACTURE WAS FOUND TO BE APPROXIMATELY 5.236IN, INDICATING THAT APPROXIMATELY 0.564 INCHES HAD BROKEN OFF THE END OF THE DRILL. REVIEWING THE SURGICAL TECHNIQUE FOR THE SMALL FRAGMENT BASE SET THE 2.0 MM QUICK RELEASE DRILL (80-2378) IS USED IN CONJUNCTION WITH THE 2.0 MM LOCKING DRILL GUIDE (80-2371) BY INSERTING THE DRILL THROUGH THE CENTER AND ADVANCING THE DRILL TO DESIRED DEPTH. MISALIGNMENT DURING INSERTION INTO THE DRILL GUIDE OR DIRECTLY DRILLING INTO INCORRECT PLATE HOLE COULD RESULT IN BREAKAGE. 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 WITH THE USE OF SMALL FRAGMENT BASE SET ANKLE 3, THE 2.0MM DRILL BIT (PART NUMBER 80-2378, BATCH NUMBER 559525) BROKE IN THE PATIENT WHILE DRILLING TO PREPARE FOR THE DISTAL LOCKING SCREW INSERTION INTO THE PLATE. THE BROKEN DRILL TIP REMAINS IN THE PATIENT AND COULD NOT BE RETRIEVED. AS A RESULT, IF THIS ISSUE, IT WAS STATED A SCREW COULD NOT BE IMPLANTED IN THAT LOCATION. IT WAS ALSO REPORTED THAT THE "SURGEON WAS LOADING THE DRILL BIT DURING USE". THIS ISSUE PROLONGED THE SURGERY BY 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45334 2.0MM QR DRILL, W/ DEPTH MARKS BIT, DRILL HTW ACUMED, LLC 80-2378 559525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown