BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2982897 · Received February 28, 2013

    Report

    Report Number
    0001811755-2013-00398
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS REPORTED THAT A WET OILY SUBSTANCE WAS FOUND INSIDE THE MOTOR HOUSING AND IN THE LEAK PATH OF THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS REPORTED THAT A WET OILY SUBSTANCE WAS FOUND INSIDE THE MOTOR HOUSING AND IN THE LEAK PATH OF THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE. A PROBABLE CAUSE OF THE REPORTED DISASSEMBLY WAS IDENTIFIED TO BE THE DECORATIVE SCREW UNTHREADING. AS THE SCREW FASTENS THE HOUSING TO THE INTERNAL COMPONENTS AND HOLDS THE BACK CAP, BACK NUT, AND BACK BRACE IN POSITION, A LOOSE SCREW MAY LEAD TO THE REPORTED DISASSEMBLY. THE SCREW CAN LOOSEN DUE TO VIBRATION DURING USE, WHICH WILL CAUSE IT TO UNTHREAD, OR FALL OFF AS A RESULT OF IMPACT FORCES. IMPROPER CLEANING AND STERILIZATION PRACTICES AND INSUFFICIENTLY DRYING THE HANDPIECE AFTER THE WASH CYCLE WERE IDENTIFIED AS PROBABLE CAUSES OF THE REPORTED SUBSTANCE FOUND IN THE DEVICE AND IN THE LEAK PATH OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE DEVICE FELL APART WHILE OPENING THE CASE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE DEVICE FELL APART WHILE OPENING THE CASE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86474 CORDLESS DRIVER 2 HANDPIECE ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1