BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4221648 · Received November 3, 2014

    Report

    Report Number
    0001811755-2014-03923
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE COULD NOT BE DUPLICATED AND NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. AS THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702867 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1