BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 2981846 · Received February 27, 2013

    Report

    Report Number
    0001811755-2013-00395
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE FAILURE COULD NOT BE CONFIRMED BECAUSE THE REPORTED EVENT OF HEAT DUE TO A BIAS-CURRENT WARNING PREVENTING THE HANDPIECE FROM RUNNING. THE TECHNICIAN NOTED THAT THE ROTOR ASSEMBLY WAS CORRODED. BASED ON (B)(6) 2013 TRENDING, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT WOULD BE THE CORRODED ROTOR ASSEMBLY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED.  A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE DEVICE OVERHEATED. HOWEVER DURING DEVICE EVALUATION, THE DEVICE DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAD THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE DEVICE OVERHEATED. HOWEVER DURING DEVICE EVALUATION, THE DEVICE DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAD THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83213 CORE SUMEX DRILL DRILL, SURGICAL, ENT ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1