BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR SYSTEM 5 SAGITTAL SAW

    MDR report key: 1842005 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01018
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IT WAS FOUND THAT THE DECORATIVE SCREW IN THE BACK OF THE DEVICE CAME OUT. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW CAME APART WHILE IN USE. THE USER FACILITY REPORTED NO ADVERSE CONSEQUENCES AND NO PT COMPLICATIONS. NO FURTHER INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK