BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 3112341 · Received May 14, 2013

    Report

    Report Number
    0001811755-2013-01114
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. A BROKEN PIECE OF BLADE WAS STUCK IN THE HANDPIECE AND COULD NOT BE REMOVED. THE BLADE MOUNT ASSEMBLY WAS REPLACED AND NORMAL FUNCTION WAS RESTORED TO THE HANDPIECE BEFORE BEING RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SYSTEM 5 SAGITTAL SAW WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS NOTED THAT A PIECE OF BLADE WAS STUCK IN THE HEAD. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 5 SAGITTAL SAW WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FAILURE ANALYSIS IT WAS NOTED THAT A PIECE OF BLADE WAS STUCK IN THE HEAD. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212808 SYSTEM 5 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BLADE