BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3083729 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00951
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF LEAKING AN UNKNOWN SUBSTANCE WAS CONFIRMED. BASED ON A REVIEW OF COMPLAINT TRENDING, THIS LIKELY OCCURRED DUE TO NON-RECOMMENDED CLEANING PROCEDURES. MAINTENANCE WAS PERFORMED ON THE DEVICE AND IT WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE CORDLESS DRIVER WAS SENT FOR EVALUATION DUE TO A TIGHT BATTERY FIT AND THE HANDPIECE WAS LEAKING A SUBSTANCE DESCRIBED AS WATER LIKE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE CORDLESS DRIVER WAS SENT FOR EVALUATION DUE TO A TIGHT BATTERY FIT AND THE HANDPIECE WAS LEAKING A SUBSTANCE DESCRIBED AS WATER LIKE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185400 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1