BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2241662 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03205
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE REAR MOTOR BEARING FAILED. A FAILED BEARING CAN CAUSE THE DEVICE TO HEAT UP DUE TO THE ADDED FRICTION WHEN BEING OPERATED. THE REAR MOTOR BEARING HAS BEEN REPLACED TO CORRECT THE FAILURE OF THE DEVICE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING. THE CUSTOMER DID NOT KNOW WHEN THE EVENT OCCURRED OR IF THERE WAS PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK