BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3130416 · Received May 24, 2013

    Report

    Report Number
    0001811755-2013-01201
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE. FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION, THE DEVICE WAS FOUND TO HAVE A NON-STRYKER E-BOX. THE E-BOX CONTROLS THE ELECTRONICS OF THE DEVICE AND USE OF A NON-STRYKER COMPONENT WILL RESULT IN CIRCUIT FAILURE, EXPLAINING THE REPORTED EVENT AND THE SERVICE FINDINGS OF THE DEVICE RUNNING IN THE WRONG MODE.

    Description of Event or Problem · 1

    THE CORDLESS DRIVER 3 WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS NOTED THAT WHEN THE HANDPIECE NEEDED TO OSCILLATE, IT RAN IN FORWARD. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE CORDLESS DRIVER 3 WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS NOTED THAT WHEN THE HANDPIECE NEEDED TO OSCILLATE, IT RAN IN FORWARD. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232772 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1