BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM QUICK RELEASE DRILL

    MDR report key: 18097984 · Received November 8, 2023

    Report

    Report Number
    3025141-2023-00621
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 7, 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 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 556526) WAS RETURNED FOR EVALUATION. THE RETURNED DRILL WAS EXAMINED WITH MAGNIFIED PHOTOGRAPHY. THE DRILL WAS BROKEN INTO TWO PIECES; A LARGER MAIN-BODY PIECE WITH THE CONNECT FEATURE AND THE MAJORITY OF THE DRILL SHAFT, AS WELL AS A SMALLER TIP PORTION. THE FLUTED DRILL FEATURE WAS MOSTLY CONTAINED ON THE TIP PORTION; THE TIP PORTION WAS ALSO SLIGHTLY BENT TOWARDS THE LOCATION OF THE BREAKAGE. DUE TO THE LENGTH OF THE MAIN BODY PORTION THE REMAINDER OF THE VISUAL APPEARANCE EXAMINATION WAS FOCUSED ON THE SMALLER TIP PORTION. BOTH PIECES TERMINATED WITH A MILDLY CUPPED FRACTURE SURFACE, WITH THE FRACTURE SURFACE BEING HIGHLY OBLIQUE/ANGLED AND THEREFORE NOT PERPENDICULAR TO THE DEVICE'S AXIS. THE REGIONS ADJACENT TO EDGES OF THE FRACTURE SURFACES EXHIBITED NO STRETCHING OR NECKING (I.E., NO DUCTILITY). SURFACES APPEAR MODERATELY BUMPY WITH SPORADIC TEXTURING AND OCCASIONAL SHARP EDGES; THERE WERE NO REGULAR OCCURRENCES OF PROGRESSION/BEACH/SEASHELL MARKS ON THE FRACTURE SURFACES (I.E. NO SIGNS OF FATIGUE). THE LOBES/FLUTES OF THE DRILL IN THE SEPARATED TIP REGION WERE MISSHAPEN; THE DISFIGURED FLUTES HAD BEEN WARPED TO REVERSE THEIR DIRECTION-OF-TWIST ALONG THE LENGTH OF THE FLUTED REGION. THE TIP/TROCAR OF THE FLUTED PORTION WAS ALSO SLIGHTLY BENT/DEFORMED AND HAD BEEN MILDLY BLUNTED; THE FLUTES OF THE DRILL THEMSELVES WERE ALSO WORN AND NOT SHARP. 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 SURGERY, THE DRILL 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 556526) BROKE DURING DRILLING BY DISTAL RADIUS. THE BROKEN PIECE OF THE DRILL DID NOT REMAIN IN THE BONE. THE SURGERY WAS COMPLETED WITH NO DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806377 2.0MM QUICK RELEASE DRILL BIT, DRILL HTW ACUMED, LLC 80-0318 556526

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown