BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 2962455 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00682
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) REVIEW FOR THE SPECIFIED LOT INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. (B)(4) REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE REFERENCED LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED SETTING TIME ISSUE CANNOT BE CONFIRMED. THE MIXING PROPERTIES OF THE RETURNED AND RETAIN SAMPLES OF THE REPORTED LOT CODE TJT058 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 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 AND 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.

    Description of Event or Problem · 1

    (B)(6), REPORTED VIA THE SALES REP THAT THE SIMPLEX CEMENT SET AFTER JUST 5 MINUTES. THE CUSTOMER ADDED THAT ANOTHER BATCH OF CEMENT WAS USED FROM THE SAME LOT NUMBER BUT THIS ALSO SET AFTER JUST 5 MINUTES. THE CUSTOMER ADDED THAT THEY STORED THE CEMENT IN TEMPERATURE CONTROLLED CONDITIONS IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE MANUAL. THE CUSTOMER REPORTED THAT A DIFFERENT LOT NUMBER WAS USED AND SURGERY WAS COMPLETED SUCCESSFULLY. THE CUSTOMER REPORTED THAT THIS LED TO APPROXIMATELY A 30 MINUTE DELAY TO SURGERY TIME. TWO UNUSED PACKS FROM THE REPORTED LOT NUMBER ARE BEING RETURNED FOR INVESTIGATION. THE REPORTED LOT NUMBER IS TO BE CONFIRMED.

    Description of Event or Problem · 1

    THE THEATRE MANAGER, AN, REPORTED VIA THE SALES REP THAT THE SIMPLEX CEMENT SET AFTER JUST 5 MINUTES. THE CUSTOMER ADDED THAT ANOTHER BATCH OF CEMENT WAS USED FROM THE SAME LOT NUMBER BUT THIS ALSO SET AFTER JUST 5 MINUTES. THE CUSTOMER ADDED THAT THEY STORED THE CEMENT IN TEMPERATURE CONTROLLED CONDITIONS IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE MANUAL. THE CUSTOMER REPORTED THAT A DIFFERENT LOT NUMBER WAS USED AND SURGERY WAS COMPLETED SUCCESSFULLY. THE CUSTOMER REPORTED THAT THIS LED TO APPROXIMATELY A 30 MINUTE DELAY TO SURGERY TIME. TWO UNUSED PACKS FROM THE REPORTED LOT NUMBER ARE BEING RETURNED FOR INVESTIGATION. THE REPORTED LOT NUMBER IS TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65919 SIMPLEX TOBRAMYCIN 1 PK IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH TJT058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other