BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSC GTS 2K 90 X 13 X 1.27MM

    MDR report key: 4723894 · Received April 21, 2015

    Report

    Report Number
    2950261-2015-00005
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 22, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE BROKE DURING USE AND WAS RECOGNIZED AFTER THE OPERATION BY THE OPERATING ROOM NURSE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BLADE BROKE AT THE DISTAL END OF THE PRODUCT. THERE WAS NO IMPACT TO THE FUNCTIONALITY OF THE DEVICE DURING USE AND BREAKAGE WAS NOT NOTED UNTIL AFTER THE SURGERY WAS COMPLETED. NO PORTION OF THE BLADE FELL INTO THE PATIENT AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION PERFORMED AND THERE ARE NO PLANS FOR ADDITIONAL FOLLOW-UP OR PROCEDURES FOR THE PATIENT. THE SURGERY BEING PERFORMED AT THE TIME OF THE REPORTED ISSUE WAS A TKA AND THE PR 4 IN 1 FLEX FEMORAL CUT GUIDE SIZE C-H ARTICLE NUMBER 00-59010-043/048-00. THE REPORTED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM AND NO SURGICAL DELAY/EXTENSION ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263202 OSC GTS 2K 90 X 13 X 1.27MM OSC GTS 2K 90 X 13 X 1.27MM GFA ZIMMER SURGICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1