BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 5429390 · Received February 10, 2016

    Report

    Report Number
    0002249697-2016-00389
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 18, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING SIMPLEX BONE CEMENT WITH TOBRAMYCIN WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICES WERE RETURNED AND NO PHOTOGRAPHS WERE PROVIDED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THERE WAS NO PATIENT INVOLVEMENT. DEVICE HISTORY REVIEW: REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. CONCLUSIONS: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS AN ODOR COMING FROM THE PRODUCT. THIS INDICATES THAT AN AMPOULE WAS BROKEN AT THE TIME OR SHORTLY BEFORE THE PRODUCT WAS RECEIVED BY THE CUSTOMER. THE LIQUID FROM THE AMPOULE HAS A VERY STRONG ODOUR AND LASTS A SHORT PERIOD OF TIME AS THE LIQUID EVAPORATES WHEN EXPOSED TO THE ATMOSPHERE. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING DURING DISTRIBUTION/TRANSPORTATION. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED SIMPLEX PACKAGING DAMAGE MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE PRODUCT. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS REFUSED SHIPMENT BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THREE BOXES OF TOBRA 6197-9-010 WERE ORDERED. THE TWO PACK CARTON ARRIVED AT THE WAREHOUSE WET AND SMELLING ON THE OUTER SHIPPING CARTON. HOSPITAL REFUSED SHIPMENT.

    Description of Event or Problem · 1

    3 BOXES OF TOBRA 6197-9-010 WERE ORDERED. THE TWO PACK CARTON ARRIVED AT THE WAREHOUSE WET AND SMELLING ON THE OUTER SHIPPING CARTON. HOSPITAL REFUSED SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85309 SIMPLEX P - US TOBRA FD 10-PK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH MJW080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other