BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 20245940 · Received September 18, 2024

    Report

    Report Number
    20245940
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    March 19, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A DRILL BIT HAD BROKEN OFF WHILE THE SURGEON WAS USING IT. OPERATIONG ROOM STAFF ATTEMPTED TO SEARCH FOR THE BROKEN PART OF THE DRILL BIT AFTER THE OTHER HALF HAD BEEN REMOVED FROM THE DRIVER. STAFF WAS UNABLE TO LOCATE THE MISSING PIECE. SO, C-ARM WAS CALLED INTO THE OPERATING ROOM TO ASSESS IF THE BIT COULD BE LOCATED IN THE PATIENT'S WOUND, FOLLOWED BY A FLAT PLATE X-RAY IMAGE. BOTH IMAGES SHOWED THAT THE PATIENT'S WOUND WAS CLEAR OF THE DRILL BIT. AFTER THAT, THE SURGEON PROCEEDED WITH THE REST OF THE SURGERY WITH NO OTHER COMPLICATIONS AND DOCUMENTED IN THE POST-OP NOTE ABOUT THE BROKEN BIT. HE REPORTED THAT 3 DRILL HOLES WERE PLACED IN THE LESSER TUBEROSITY FOR REPAIR OF OUR SUBSCAPULARIS, AND THAT IT WAS THE THIRD DISTAL DRILL HOLE THAT RESULTED IN A BROKEN DRILL BIT. THERE WAS NO HARM DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067186 MICROAIRE BIT, DRILL HTW MICROAIRE SURGICAL INSTRUMENTS LLC 8054-011

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female