BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNUM SAW BLADE GUARD

    MDR report key: 809100 · Received January 11, 2007

    Report

    Report Number
    1017294-2006-00613
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 13, 2006
    Report Date
    December 14, 2006
    Manufacturer
    CONMED LINVATEC
    Product Code
    KFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE PRODUCT WAS RECEIVED FOR EVAL AND THE REPORTED PROBLEM WAS CONFIRMED. A VISUAL INSPECTION OF THE DEVICE FOUND THAT THE SHAFT WAS BROKEN. THIS DAMAGE CAN OCCUR, AS THE SHAFT OF THE STERNUM GUARD CAN BECOME DAMAGED/BENT OVERTIME FROM HANDLING/USE. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS FOUND NO OTHER REPORTED EVENTS FOR THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS BLADE GUARD, IT BROKE AND FELL INTO THE SURGICAL SITE. THE BROKEN PORTION WAS RETRIEVED AND AN ALTERNATE BLADE GUARD WAS USED. THERE WAS NO PT INJURY NOR DELAY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERNUM SAW BLADE GUARD BLADE GUARD KFK CONMED LINVATEC NA P-04-98

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR