BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2050020 · Received March 14, 2011

    Report

    Report Number
    1811755-2011-00794
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE MOUNT OPENING ON THE SAW WAS CHIPPED. THIS WAS DISCOVERED BY AN ONSITE SERVICE TECHNICIAN DURING A ROUTE MAINTENANCE VISIT. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK