BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4091949 · Received September 16, 2014

    Report

    Report Number
    0001811755-2014-03251
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT OF OVERHEATING, AND NOTED THAT THE DRIVESHAFT ASSEMBLY WAS CORRODED. IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE CORRODED DRIVESHAFT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE CORE IMPACTION DRILL IS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE CORE IMPACTION DRILL IS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572558 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1