BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3083745 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00959
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 WAS NOT DUPLICATED AND NO FAILURES WERE CONFIRMED AS THE PRODUCT FOR THIS INVESTIGATION WAS NOT AVAILABLE FOR EVALUATION. DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT WAS GETTING WARM 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 WAS GETTING WARM 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
    183385 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1