BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3772383 · Received April 25, 2014

    Report

    Report Number
    0001811755-2014-01495
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FAILURE OF RUN ON WAS NOT CONFIRMED THROUGH FUNCTIONAL TESTING, DISASSEMBLY AND VISUAL INSPECTION. THROUGH VISUAL INSPECTION, THE REPAIR TECHNICIAN CONFIRMED THE OTHER PARTS WERE DAMAGED AND CORRODED. THE AFFECTED PARTS WERE REPLACED. THE DRILL WAS REPAIRED AND RETURNED TO THE CUSTOMER AFTER PASSING FINAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS SEIZING DURING A PROCEDURE AT USER FACILITY. CUSTOMER COULD NOT CONFIRM IF THE DEVICE RAN WITHOUT ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS SEIZING DURING A PROCEDURE AT USER FACILITY. CUSTOMER COULD NOT CONFIRM IF THE DEVICE RAN WITHOUT ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252677 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1