BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2803016 · Received October 17, 2012

    Report

    Report Number
    1811755-2012-03833
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SYSTEM 5 SAGITTAL SAW WAS SENT FOR EVAL BECAUSE THE DECORATIVE SCREW FELL OUT OF THE SAW CAUSING THE HANDPIECE TO DISASSEMBLE DURING A PROCEDURE. THE HANDPIECE DISASSEMBLED AND FELL INTO THE STERILE SURGICAL FIELD, BUT DID NOT FALL INTO THE SURGICAL SITE. THE PT WAS ADMINISTERED ADDITIONAL ANTIBIOTICS AS A PRECAUTIONARY MEASURE. THE CASE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE WITHOUT ANY CLINICALLY SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK