BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 3162214 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01855
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT WAS CONFIRMED. EVALUATION OF THE PHOTOGRAPHS SHOWS THE BROKEN AMPOULE AND LEAKAGE DAMAGE TO THE AMPOULE BLISTER. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS AN ODOUR COMING FROM THE PRODUCT WHEN THE REPORTED DAMAGE WAS NOTED. 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 IMAGES PROVIDED THERE IS SOME EVIDENCE OF INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ITEM # 6197-9-010, QTY (B)(4), LOT CODE MAU006, WAS SHIPPED DIRECTLY TO (B)(6). (B)(6) AT THE HOSPITAL NOTICED THE PRODUCT WAS DESTROYED, THE CEMENT DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ITEM # 6197-9-010, QTY 1, LOT CODE MAU006, WAS SHIPPED DIRECTLY TO (B)(6) MEDICAL CENTER. (B)(6) AT THE HOSPITAL NOTICED THE PRODUCT WAS DESTROYED, THE CEMENT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261998 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MAU006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other