BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR U2 DRILL

    MDR report key: 1873481 · Received October 14, 2010

    Report

    Report Number
    1811755-2010-01400
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MANUFACTURER, HOWEVER, THE OVERHEATING COMPLAINT COULD NOT BE REPLICATED. DURING THE DEVICE EVALUATION, IT WAS NOTICED THAT THE DEVICE WAS EXCESSIVELY NOISY, PROMPTING FURTHER INVESTIGATION. INTERNAL COMPONENTS WERE EVALUATED AND THE ROTOR BEARINGS WERE DISCOVERED TO BE MISSING THE REQUIRED LUBRICATION. IF LUBRICATION IS NOT PRESENT, HEAT COULD BE GENERATED AMONG ROTATING COMPONENTS. THE ROTOR ASSEMBLY AND BEARINGS WERE REPLACED, AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED PRIOR TO THE START OF A SURGICAL PROCEDURE, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY TO THE SCHEDULED PROCEDURE. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR U2 DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK