BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP, SCN T2 SCN

    MDR report key: 5116381 · Received October 1, 2015

    Report

    Report Number
    0009610622-2015-00457
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540378613
    PMA / PMN Number
    K023267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    A GENERAL EVALUATION BY A CONSULTANT HCP REGARDING THE POTENTIAL RISK OF INFECTION CAUSED BY STERILE (GAMMA STERILIZATION OR EO STERILIZATION) PACKED STRYKER IMPLANTS AND INSTRUMENTS COMES TO THE CONCLUSION THAT ¿ALTHOUGH THERE IS A NEGLIGIBLE PROBABILITY THAT AN INFECTION HAS BEEN CAUSED BY A STERILE PACKED DEVICE BY AN EVENT IN THE FIELD OF RESPONSIBILITY OF STRYKER, THE FOLLOWING MEASURES ARE RECOMMENDED IN THE CASE OF A RESPECTIVE COMPLAINT DUE TO FORMAL REASONS: ¿ REVIEW OF THE PACKAGING PROCESS (PRIOR TO STERILIZATION) DOCUMENTS. ¿ REVIEW OF THE STERILIZATION DOCUMENTS. ¿ REVIEW OF THE STORAGE AND DELIVERY DOCUMENTS. IF NONE OF THE NOMINATED DOCUMENTS OFFERS A DEVIATION, THE AFFECTED STERILE PACKED STRYKER DEVICE CAN BE EXCLUDED AS ROOT CAUSE OF THE REPORTED INFECTION WITH ALMOST ABSOLUTE CERTAINTY AND NO FURTHER ACTION IS REQUIRED FROM A CLINICAL POINT OF VIEW [...]¿ ACCORDING TO THE ABOVE STATEMENT THE PACKAGING, STERILIZATION AND STORAGE/DELIVERY DOCUMENTS WERE REVIEWED FOR THE LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM AND ALL OTHER IMPLANTS REPORTED; NO ABNORMALITIES OR DEVIATIONS WERE FOUND. BASED ON THE ABOVE OBSERVATIONS A RELATIONSHIP TO THE REPORTED INFECTION CAN BE EXCLUDED; THERE IS NO ASSUMPTION THAT THE REPORTED STRYKER IMPLANTS HAVE CAUSED THE INFECTION, WHICH IS ALSO IN ACCORDANCE WITH THE STATEMENTS OF THE SALES REP AND THE PHYSICIAN IN THE HOSPITAL WHO EXCLUDE THE IMPLANTS TO HAVE CAUSED THE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650961 END CAP, SCN T2 SCN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K06DC3F 04546540378613

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention