BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 7977027 · Received October 18, 2018

    Report

    Report Number
    7977027
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 12, 2018
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE USING A DRILL, THE TIP BROKE OFF INTO THE IMPLANT. THE ATTENDING SURGEON DEEMED IT BEST AND SAFEST TO LEAVE THE DRILL BIT TIP IN PLACE RATHER THAN EXTEND SURGERY TIME AND RISK DISLOCATING THE JOINT IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818804 MICROAIRE BIT, DRILL HTW MICROAIRE SURGICAL INSTRUMENTS LLC 8054-010

    Patients

    Seq Age Sex Outcome Treatment
    1 30295 DA Other