BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVASIVE

    MDR report key: 1982212 · Received February 3, 2011

    Report

    Report Number
    MW5019308
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 2, 2010
    Manufacturer
    SYNVASIVE
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) WOMAN WAS HAVING AN ELECTIVE TOTAL KNEE REPLACEMENT SURGERY. DURING THE SURGERY, THE SYNVASIVE SAW BLADE BROKE AT THE POINT OF ITS CONNECTION TO THE POWER SOURCE/DRILL. THE BLADE AND ALL PIECES WERE EASILY RETRIEVED AND NO HARM WAS CAUSED TO THE PT; THE PROCEDURE PROCEEDED AS PLANNED. THE REP WAS CONTACTED AND THE PIECES WILL BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVASIVE "STABLE CUT" SAW BLADE GFA SYNVASIVE 11-3314 03120

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR