BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 6328742 · Received February 14, 2017

    Report

    Report Number
    0002249697-2017-00547
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    February 17, 2016
    Report Date
    April 12, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: 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 HAS BEEN ONE OTHER EVENT FOR THE REPORTED LOT. THIS OTHER EVENT IS FOR THE SAME SURGERY. 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.

    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. NOT AVAILABLE.

    Description of Event or Problem · 1

    SIMPLEX WITH TOBRAMYCIN BONE CEMENT SET IN 2 MINS 30 SECS (MIXED IN ACM). WAS NOTICED BEFORE IMPLANTATION; CEMENT DISCARDED AND NEW MIX USED SUCCESSFULLY IN PATIENT TO COMPLETE SURGERY.

    Description of Event or Problem · 1

    SIMPLEX WITH TOBRAMYCIN BONE CEMENT SET IN 2 MINS 30 SECS (MIXED IN ACM). WAS NOTICED BEFORE IMPLANTATION; CEMENT DISCARDED AND NEW MIX USED SUCCESSFULLY IN PATIENT TO COMPLETE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113451 SIMPLEX TOBRAMYCIN 1 PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH THW040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other