BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 8112630 · Received November 28, 2018

    Report

    Report Number
    0002249697-2018-03847
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 29, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING FOREIGN MATTER FOUND IN SIMPLEX CEMENT MIX WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE DEVICE IN QUESTION AND REPORTED FOREIGN MATTER COULD NOT BE COMPLETED AS IT WAS NOT RETURNED, HOWEVER, AS THERE WERE TWO REPORTED EVENTS FOR THIS SIMPLEX LOT RETAIN SAMPLES OF THE POWDER AND LIQUID COMPONENTS WERE UNDERTAKEN BY THE LAB TO REVIEW FOR FOREIGN MATTER. THE ANALYSIS INDICATED NO FOREIGN MATTER PRESENCE IN ANY OF THE RETAIN SAMPLES INSPECTED. -MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE WERE ONE OTHER SIMILAR REPORTED EVENT FOR THE LOT REFERENCED. CONCLUSION: TWO INCIDENTS OF FOREIGN MATTER WITHIN MIXED SIMPLEX CEMENT WERE REPORTED FROM THE SAME HOSPITAL. THE EVENT COULD NOT BE CONFIRMED AS NO IMAGES WERE PROVIDED AND NO PRODUCT WAS RETURNED. VISUAL INSPECTION OF THE DEVICE IN QUESTION AND REPORTED FOREIGN MATTER COULD NOT BE COMPLETED AS IT WAS NOT RETURNED, HOWEVER, AS THERE WERE TWO REPORTED EVENTS FOR THIS SIMPLEX LOT RETAIN SAMPLES OF THE POWDER AND LIQUID COMPONENTS WERE UNDERTAKEN BY THE LAB TO REVIEW FOR FOREIGN MATTER. THE ANALYSIS INDICATED NO FOREIGN MATTER PRESENCE IN ANY OF THE RETAIN SAMPLES INSPECTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING IMAGES OF THE REPORTED ISSUE AND RETURN OF THE PRODUCT IN QUESTION ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT SHARDS OF GLASS HAVE BEEN REPORTED IN THE SIMPLEX CEMENT BATCH DURING TWO OPERATIONS. PI 1931867 WAS RAISED FOR THE OTHER OPERATION.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE BATCH MANUFACTURING RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FOR SIMILAR REPORTED EVENTS REGARDING GLASS IN CEMENT MIX. THERE HAVE BEEN ONE OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THIS EVENT WAS REPORTED ON SAME DAY FROM SAME HOSPITAL. PRODUCT NOT AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHARDS OF GLASS HAVE BEEN REPORTED IN THE SIMPLEX CEMENT BATCH DURING TWO OPERATIONS. (B)(4) WAS RAISED FOR THE OTHER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949132 SIMPLEX TOBRAMYCIN 1 PK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH THZ031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other