BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 PRECISION HANDPIECE

    MDR report key: 3850813 · Received June 5, 2014

    Report

    Report Number
    0001811755-2014-02060
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED RUNNING TOO FAST WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, IT WAS FOUND THAT A THIRD PARTY E-BOX AND MOTOR HAD BEEN INSTALLED. UNAUTHORIZED MODIFICATION OF THESE COMPONENTS IS A PROBABLE CAUSE OF RUNNING TOO FAST . THE DEVICE INSTRUCTIONS FOR USE STATES THAT NO SERVICE SHOULD BE ATTEMPTED ON THE DEVICE SYSTEM COMPONENTS AND THAT ALL CONCERNS SHOULD BE DIRECTED TO STRYKER SERVICE. STRYKER RECOMMENDS THAT ALL FAILURES AND MAINTENANCE ASSOCIATED WITH ITS DEVICES SHOULD BE DIRECTED TO TRAINED STRYKER SERVICE PROFESSIONALS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE DEVICE WAS RUNNING FASTER THAN THE EXPECTED SPEED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE DEVICE WAS RUNNING FASTER THAN THE EXPECTED SPEED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330190 SYSTEM 6 PRECISION HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1