BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSC GTS 2K 90 X 25 X 1.19MM

    MDR report key: 4996280 · Received August 12, 2015

    Report

    Report Number
    2950261-2015-00011
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    June 8, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER 25090119SG1, LOT NUMBER IS UNKNOWN, WAS RETURNED TO ZIMMER SURGICAL FOR INITIAL PRODUCT CONDITION/VISUAL EXAMINATION EVALUATION AND FUNCTIONAL TESTS. EVALUATION OF THE DEVICE NOTED THAT ONE TOOTH LOCATED AT THE LAST EDGE POSITION IS BROKEN FROM THE BLADE. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE EXTENT OF THE DAMAGE. MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS NOT KNOWN. THE REPORTED EVENT "THAT DURING A TOTAL KNEE REPLACEMENT, ONE OF THE TEETH ON THE BLADE CAME OFF; THE BROKEN TOOTH AND THE BLADE WERE NOTICED ON THE MAYO" WAS CONFIRMED PER THE INITIAL PRODUCT CONDITION/VISUAL EXAMINATION EVALUATION. ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME, BUT COULD BE ASSOCIATED WITH THE SAW BLADE COMING IN CONTACT WITH THE CUTTING GUIDE OR OTHER HARD SURFACE. COMPLAINTS OF THIS NATURE WILL BE TRACKED AND TRENDED TO DETERMINE WHAT, IF ANY, ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, ONE OF THE TEETH ON THE BLADE CAME OFF. THE BROKEN TOOTH AND THE BLADE WERE NOTICED ON THE MAYO. ADDITIONAL CLARIFICATION NOTED THAT THE MAYO IS THE SMALL TABLE THAT HOLDS THE INSTRUMENTS. NO PORTION OF THE BLADE FELL INTO THE SURGICAL SITE. THERE WAS NO REPORT OF THE BLADE MAKING IMPACT WITH A CUTTING BLOCK OR OTHER HARD OBJECT; HOWEVER ADDITIONAL INFORMATION RECEIVED STATED THAT A CUTTING BLOCK IS USED AND THE CUTTING BLOCK COULD HAVE HAD A SPUR ON IT. THERE WAS NO REPORT OF PATIENT OR USER HARM OR SURGICAL DELAY ASSOCIATED WITH THE REPORT. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529398 OSC GTS 2K 90 X 25 X 1.19MM OSC GTS 2K 90 X 25 X 1.19MM GFA SYNVASIVE TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1