BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 4221408 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04111
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: PHOTOGRAPHS OF THE PACK WERE PROVIDED. THE SHIPPER BOX FOR THE TEN-PACK APPEARS TO HAVE A COMPRESSION MARK ON ONE CORNER WHERE IT APPEARS IT WAS DROPPED. THERE IS ONE TEN-PACK WITHIN THE SHIPPER BOX. PHOTOGRAPHS OF THE UNIT CARTONS WITHIN THE SHIPPER BOX WERE NOT PROVIDED THEREFORE THE CONDITION OF THE CONTENTS OF THE TEN-PACK IT IS NOT KNOWN. 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 ODOUR COMING FROM THE PRODUCT WHEN THE PRODUCT WAS RECEIVED AT THE HOSPITAL. THIS INDICATES THAT AN AMPOULE(S) WAS BROKEN AT THE TIME OR SHORTLY BEFORE THE PRODUCT WAS RECEIVED BY THE CUSTOMER AS THE SMELL WOULD HAVE COME FROM THE MONOMER WHEN THE AMPOULE WAS BROKEN. THIS ODOUR FROM THE MONOMER LIQUID 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.

    Description of Event or Problem · 1

    HOSPITAL RECEIVED PACKAGE FROM (B)(6) TODAY AND SAID THE BOX WAS WRAPPED IN A CLEAR WHITE BAG. THEY INSTANTLY NOTICED AN ODOR WHEN REMOVED FROM BAG. BOX WAS NOT PHYSICALLY DAMAGED BUT WHEN SHE OPENED THE BOX THE ODOR WAS EVEN STRONGER.

    Description of Event or Problem · 1

    HOSPITAL RECEIVED PACKAGE FROM (B)(6) TODAY AND SAID THE BOX WAS WRAPPED IN A CLEAR WHITE BAG. THEY INSTANTLY NOTICED AN ODOR WHEN REMOVED FROM BAG. BOX WAS NOT PHYSICALLY DAMAGED, BUT WHEN SHE OPENED THE BOX THE ODOR WAS EVEN STRONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701007 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MDV028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other