BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 3093535 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01555
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE ONE RETURNED SAMPLE AND TWO RETAIN 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 E.G. 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 ONE RETURNED SAMPLE AND TWO RETAIN SAMPLES OF THE REPORTED LOT CODE TAU003 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST BATCH OF DOUBLE MIX CEMENT MIXED, AND THERE WAS UNMIXED CEMENT IN THE ACM CARTRIDGE, AND THE CEMENT HAD ALSO STARTED TO SET BEFORE THE SURGEON IMPLANTED. A SECOND BATCH OF CEMENT WAS MIXED IN ACM AND THIS ALSO STARTED TO SET BEFORE THE SURGEON IMPLANTED. SURGEON MIXED A THIRD BATCH AND CEMENT WHICH HAD BEEN COOLED, IN THE ACM MIXING SYSTEM, AND THIS WAS EXPECTED CONSISTENCY, AND WAS ABLE TO BE IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST BATCH OF DOUBLE MIX CEMENT MIXED, AND THERE WAS UNMIXED CEMENT IN THE ACM CARTRIDGE, AND THE CEMENT HAD ALSO STARTED TO SET BEFORE THE SURGEON IMPLANTED. A SECOND BATCH OF CEMENT WAS MIXED IN ACM AND THIS ALSO STARTED TO SET BEFORE THE SURGEON IMPLANTED. SURGEON MIXED A THIRD BATCH AND CEMENT WHICH HAD BEEN COOLED, IN THE ACM MIXING SYSTEM, AND THIS WAS EXPECTED CONSISTENCY, AND WAS ABLE TO BE IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197276 SIMPLEX TOBRAMYCIN 1 PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other