BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 1841974 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01009
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 SCREW IN BACK OF THE HANDPIECE CAME OUT DURING A PROCEDURE. THERE WERE NO REPORTS OF THE SCREW FALLING INTO PATIENT. AN AVAILABLE BACKUP WAS USED TO COMPLETE THE CASE WITH NO DELAY. THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES ASSOCIATED WITH 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