BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN T2 FEMORAL NAIL

    MDR report key: 10737610 · Received October 26, 2020

    Report

    Report Number
    0009610622-2020-00600
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 15, 2020
    Report Date
    October 26, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM UNIVERSITY OF CINCINNATI MEDICAL CENTER, IN USA. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF FEMUR FRACTURES WITH THE T2 FEMORAL NAILING SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 FEMORAL NAILING SYSTEM¿. THIS STUDY INCLUDES RESEARCH DONE ON 52 PATIENTS REQUIRING SURGERY BETWEEN THE PERIOD FEBRUARY 15, 2017 TO SEPTEMBER 1, 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DELAYED UNION WHICH WAS TREATED CONSERVATIVELY. THE REPORT STATES: ¿PATIENT NINE AT THEIR 8-MONTH FOLLOW-UP WAS THOUGHT TO HAVE LITTLE BONE CONSOLIDATION AND CONCERN OF NON-UNION. HOWEVER, A CT SCAN WAS ORDERED THAT SHOWED BRIDGING CALLUS, INDICATING A DELAYED UNION (I.E. HEALING SLOWER THAN EXPECTED) AND WAS TREATED CONSERVATIVELY AND ULTIMATELY HEALED AND ADVISED TO FOLLOW-UP ON AN AS-NEEDED BASIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199263 UNKNOWN T2 FEMORAL NAIL IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention