BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB MICRO DRILL

    MDR report key: 3233947 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01688
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS CORRECTED FOR A CONCOMITANT CONSOLE. THE REPORTED EVENT WAS NOT DUPLICATED. HOWEVER, AN OILY SUBSTANCE WAS FOUND TO BE AFFECTING THE MOTOR OF THE DEVICE WHICH COULD INTERFERE WITH THE ELECTRICITY AND CAN CAUSE AN INTERFERENCE WITH THE CONSOLE READING. THE MOTOR AND ALL NON-CONFORMING PARTS WERE REPLACED. IT WAS FOUND THAT ALL OF THE CONCOMITANT CONSOLES DISPLAYED A BIAS CURRENT WARNING BY THE SERVICE TECHNICIAN THROUGH FUNCTIONAL EVALUATION. DAMAGED HANDPIECE CONNECTORS WERE FOUND DURING THE DEVICE INSPECTION. BASED ON A REVIEW OF THE RISK DOCUMENTS AND OBSERVATIONS FROM THE DEVICE INSPECTION, THE PRESENCE OF DAMAGED HANDPIECE CONNECTORS MAY CAUSE OR CONTRIBUTE TO A BIAS CURRENT WARNING.

    Additional Manufacturer Narrative · 1

    CORRECTED BASED UPON ADDITIONAL INFORMATION FROM THE CUSTOMER THAT THERE WAS NO OVERHEATING. DEVICE CODE WAS UPDATED BY REMOVING OVERHEATING OF DEVICE OR DEVICE COMPONENT BASED UPON ADDITIONAL INFORMATION FROM THE CUSTOMER THAT THERE WAS NO OVERHEATING.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE REMB MICRO DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE REMB MICRO DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE REMB MICRO DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. IT WAS ALSO REPORTED THAT THE DEVICE OVERHEATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333709 REMB MICRO DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 CORE CONSOLE 5400050000, SERIAL NUMBER: (B)(4)| CORE CONSOLE 5400050000, SERIAL NUMBER: (B)(4)| CORE CONSOLE 5400050000, SERIAL NUMBER: (B)(4)| CORE CONSOLE 5400050000, SERIAL NUMBER: (B)(4)| CORE CONSOLE 5400050000, SERIAL NUMBER: (B)(4)