BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QUICK RELEASE DRILL

    MDR report key: 17656555 · Received August 30, 2023

    Report

    Report Number
    3025141-2023-00426
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 30, 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

    THE PART NUMBER 80-0318 2.0MM QUICK RELEASE DRILL WITH BATCH/LOT NUMBER 568741 WAS RETURNED FOR EVALUATION. THIS DRILL WAS USED IN AN ELBOW PLATING SYSTEM CASE AND BROKE WHILE DRILLING INTO THE HUMERUS PER THE EVENT DESCRIPTION; A PORTION OF THE DRILL WAS NOT RETURNED. THE RETURNED DEVICE WAS EXAMINED WITH MAGNIFIED PHOTOGRAPHY. OBSERVED PHENOMENA INCLUDED: LIGHT WEAR WAS PRESENT ALONG THE FLUTED PORTION OF THE DRILL. THERE WERE DOTS OF BROWN DISCOLORATION (I.E. POTENTIAL CORROSION) AT LOCATIONS ON THE FLUTES. CHIPPING/PITTING WAS PRESENT SPORADICALLY ALONG THE DRILL'S FLUTES, WHICH WERE DULL TO THE TOUCH. A PORTION OF THE DRILL HAD BROKEN OFF OF THE TIP. THE BREAK SURFACE WAS PERPENDICULAR TO THE AXIS OF THE DRILL WITH A SMALLER OFF-AXIS/OBLIQUE PLANE ON ONE OF THE FLUTES; THE FRACTURE PLANE APPEARED LARGELY FLAT AND LIGHTLY TEXTURED WITH NO NOTICEABLE NECKING OR DUCTILITY (I.E. SUGGESTS BRITTLE FRACTURE WITH FAILURE MODE OCCURRING UNDER TORSIONAL LOADING). MEASUREMENTS WERE OBTAINED. THE OVERALL LENGTH PER PRINT IS 5.75 INCHES. THE DEVICE MEASURED 5.1930 INCHES. THEREFORE, THE CALCULATED/ESTIMATED MISSING TIP LENGTH OF 0.5570 INCHES. OBSERVED PHENOMENA SUGGESTS THAT THIS DRILL HAD EXPERIENCED WEAR THROUGH PRIOR USAGE. WEARING ON INSTRUMENTATION CAN OCCUR DUE TO LONG-TERM USE AND/OR INTENSITY OF USE. IN SOME CASES, WEAR ON INSTRUMENTATION MAY CONTRIBUTE TO PERCEIVED DIFFICULTIES DURING USE; FOR DRILLS SPECIFICALLY, WEAR ON THE CUTTING FLUTES MAY INCREASE FRICTION DURING DRILLING. THIS POTENTIAL DECREASE IN CUTTING/DRILLING PERFORMANCE MAY RESULT IN DIFFICULTIES DURING USE AND/OR MAY CONTRIBUTE TO BREAKAGES. THE OBSERVED BREAKAGE (I.E. LARGELY FLAT FRACTURE PLANE, LIGHT TEXTURING, NO NECKING OR DUCTILITY) AND EVENT DESCRIPTION MAY SUGGEST THAT FAILURE COULD HAVE POTENTIALLY OCCURRED UNDER TORSIONAL LOADING; DRILL FRACTURE WAS LIKELY BRITTLE IN NATURE. TORSIONAL FAILURE MAY OCCUR IN A DEVICE THAT BECOMES OVERLOADED DURING TORSIONAL/TWISTING LOADS. THE SMALLER OFF-AXIS/OBLIQUE FRACTURE PLANE ON ONE OF THE FLUTES MAY INDICATE OFF-AXIS LOADS WERE IMPARTED TO THE DEVICE DURING USE. 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 INTO THE PATIENT'S HUMERUS WITH A 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318), WHEN THE TIP BROKE OFF IN THE PATIENT'S BONE. IT WAS ALSO REPORTED THAT THE SURGEON RETRIEVED THE BROKEN PIECE AND COMPLETED THE SURGERY AFTER A 5-MINUTE DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603145 2.0MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0318 568741

    Patients

    Seq Age Sex Outcome Treatment
    1 Male