BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 1062227 · Received June 18, 2008

    Report

    Report Number
    9616696-2008-00016
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE VISUALLY INSPECTED AND ONE TAB WAS BROKEN OFF THE BLADE MOUNT. HOWEVER, THE SIDES OF THE BLADES SHOW A HIGH LEVEL OF IMPACT MARKS. THIS CAN OCCUR IF THE EDGES OF THE BLADE REPEATEDLY STRIKE A HARD SURFACE SUCH AS THE JIG. INITIAL REVIEW WOULD INDICATE THAT THE HIGH LEVEL OF IMPACT MARKS ON THE SIDES OF THE BLADES CONTRIBUTED TO THE TAB BREAKING AT THE MOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE BROKE DURING AN OPERATION. FRAGMENTS OF BLADE WENT INTO SOFT TISSUE, HOWEVER THEY WERE REMOVED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CUT SAGITTAL BLADE SAW BLADES AND ACCESSORIES GFA STRYKER INSTRUMENTS 07352017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK