BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 3690536 · Received March 20, 2014

    Report

    Report Number
    0002249697-2014-00826
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. REVIEW DETERMINED THAT THERE WAS NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. THE EVENT WAS NOT CONFIRMED AS THE REPORTED PRODUCT OR PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. IT IS REPORTED THAT THE AMPOULE WAS BROKEN BUT THERE WAS NO ODOUR AS ALL LIQUID HAD EVAPORATED. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE DESCRIPTION OF THE EVENT, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION. (B)(4) WAS RAISED IN (B)(4) 2010 TO ADDRESS A TREND NOTED FOR DAMAGE TO SIMPLEX PACKAGING. THIS TREND WAS BASED ON THE VOLUME OF COMPLAINTS RECEIVED ASSOCIATED WITH PACKAGING DAMAGE FOR SIMPLEX PRODUCT. UPON APPLICATION OF ADVERSE TREND DETECTION IT WAS DETERMINED THAT THE RATE IS WITHIN THE RISK ACCEPTABILITY CRITERIA. PACKAGE DESIGN REVIEW WAS CARRIED OUT AS PART OF THE NCR AND IT WAS DETERMINED THAT FURTHER DESIGN REVIEW WILL BE COMPLETED UNDER PACKAGING INNOVATION QUALITY IMPROVEMENT PROJECTS. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME AS NO PRODUCT AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    AS REPORTED FROM SALESMAN, THE AMPOULE HAD BEEN FOUND BROKEN ONCE THE NURSE TOOK OUT FROM THE PACK. ALL LIQUID HAD BEEN EVAPORATED FROM THE BOTTLE.

    Description of Event or Problem · 1

    AS REPORTED FROM SALESMAN, THE AMPOULE HAD BEEN FOUND BROKEN ONCE THE NURSE TOOK IT OUT FROM THE PACK. ALL LIQUID HAD BEEN EVAPORATED FROM THE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167473 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other