BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 2974343 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00355
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OVERHEATING WAS DUPLICATED BY A MANUFACTURER SERVICE TECHNICIAN THROUGH FUNCTIONAL EVALUATION. A LACK OF LUBRICATION WAS IDENTIFIED IN THE UPPER ASSEMBLY, AND IS THE PROBABLE CAUSE OF THE REPORTED EVENT. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT OVERHEATED DURING PERFORMANCE TESTING. THE EVENT OCCURRED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT OVERHEATED DURING PERFORMANCE TESTING. THE EVENT OCCURRED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78748 SAGITTAL SAW ATTACHMENT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1