BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE DRILL

    MDR report key: 3692006 · Received March 18, 2014

    Report

    Report Number
    3692006
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 8, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL RECONSTRUCTION IN THE OR ROOM, THE MICROAIRE DRILL STOPPED WORKING. ANOTHER MICROAIRE DRILL WAS OBTAINED AND USED FOR THE REMAINDER OF THE PROCEDURE. INITIAL DRILL WAS SENT OUT FOR REPAIR AND THE COMPANY REP HAS PROVIDED A LOANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157922 MICROAIRE DRILL DRILL, BONE, POWERED HTW MICROAIRE SURGICAL INSTRUMENTS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *