BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE TOBRA FD 10-PK

    MDR report key: 3024033 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01143
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAIN AND THREE RETURNED SAMPLES OF THIS LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. THE MIXING CHARACTERISTICS AND WORKING PROPERTIES OF SURGICAL SIMPLEX BONE CEMENTS ARE INFLUENCED PRIMARILY BY THE TEMPERATURE OF THE LIQUID AND POWDER COMPONENTS AT THE TIME OF MIXING AND BY THE TEMPERATURES OF THE UTENSILS WITH WHICH IT CONTACTS DURING MIXING, EG, MIXING BOWLS, CEMENT INTRODUCERS ETC. GENERALLY, HIGHER TEMPERATURES ACCELERATE THE POLYMERISATION REACTION AND LOWER TEMPERATURES DELAY IT. OTHER FACTORS WHICH CAN AFFECT SETTING TIME ARE MIXING TECHNIQUE (SPEED, USE OF VACUUM, CENTRIFUGATION), THOROUGHNESS OF MIXING, COMPLETE UTILIZATION OF ALL OF THE POWDER & LIQUID AND CARE TO AVOID INCLUSION OF ANY EXTRANEOUS MATERIAL SUCH AS BLOOD OR STERILISATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. THE MIXING PROPERTIES OF THE THREE RETAIN AND THREE RETURNED SAMPLES OF THE REPORTED LOT CODE TKT062 WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. IT WAS NOT POSSIBLE TO REPLICATE THIS EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT HARDENED IN LESS THAN 12 MINUTES. IT WAS ADDITIONALLY REPORTED THAT THE CEMENT WAS MIXED FOR 1M15S IN A MIXER, AT 3M IT REACHED A DOUGHY PHASE, 8M30S, IT WAS WARM, AT 9 MINUTES IT WAS REPORTED IT WAS VERY HOT AND AT 9M30S IT WAS HARD. IT WAS REPORTED THAT THE CEMENT WAS KEPT AT ROOM TEMPERATURE FOR 2 HOURS PRIOR TO USE. ROOM TEMPERATURE WAS DOCUMENTED AT 70 DEG F AND ROOM HUMIDITY WAS 34%. IT WAS ALSO REPORTED THAT THE IFU STATES THAT CEMENT HARDENS IN 12 MINUTES AT ROOM TEMPERATURE 70 DEG F.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT HARDENED IN LESS THAN 12 MINUTES. IT WAS ADDITIONALLY REPORTED THAT THE CEMENT WAS MIXED FOR 1M, 15S IN A MIXER, AT 3M IT REACHED A DOUGHY PHASE, 8M 30S, IT WAS WARM, AT 9 MINUTES IT WAS REPORTED IT WAS VERY HOT AND AT 9 M 30S, IT WAS HARD. IT WAS REPORTED THAT THE CEMENT WAS KEPT AT ROOM TEMPERATURE FOR 2 HOURS PRIOR TO USE. ROOM TEMPERATURE WAS DOCUMENTED AT 70 DEG F AND ROOM HUMIDITY WAS 34%. IT WAS ALSO REPORTED THAT THE IFU STATES THAT CEMENT HARDENS IN 12 MINUTES AT ROOM TEMPERATURE 70 DEG F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126563 SIMPLEX P - CE TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH TKT062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other