BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 6219112 · Received January 3, 2017

    Report

    Report Number
    0002249697-2017-00028
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 5, 2016
    Report Date
    March 28, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SETTING TIME INVOLVING SIMPLEX WITH TOBRAMYCIN BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAINED SAMPLES TESTED FROM THE REPORTED LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. HOWEVER, NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. -DEVICE HISTORY REVIEW: BMR REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETAINED SAMPLES OF THE REPORTED LOT CODE WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. 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 POLYMERIZATION 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 STERILIZATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. BASED ON THE LABORATORY RESULTS OF THE RETAIN SAMPLES IT IS NOT POSSIBLE TO REPLICATE THIS EVENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ORTHOPEDIC NURSE REPORTED AN ISSUE WITH MULTIPLE BATCHES OF SIMPLEX TOBRA CEMENT THAT SET UP IN 5 MINS AND 8 MINS AFTER 60 SECOND MIX IN A TOWER MIXER. THE STORAGE OF THE CEMENT HAS BEEN THE SAME PLACE FOR SEVERAL YEARS.

    Description of Event or Problem · 1

    ORTHOPEDIC NURSE REPORTED AN ISSUE WITH MULTIPLE BATCHES OF SIMPLEX TOBRA CEMENT THAT SET UP IN 5 MINS AND 8 MINS AFTER 60 SECOND MIX IN A TOWER MIXER. THE STORAGE OF THE CEMENT HAS BEEN THE SAME PLACE FOR SEVERAL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365 SIMPLEX P - US TOBRA FD 10-PK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH MHX080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other