BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN T2 HUMERUS NAIL

    MDR report key: 12354737 · Received August 23, 2021

    Report

    Report Number
    0009610622-2021-00657
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 23, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PMCF CONDUCTED BY DEPARTMENT OF TRAUMA, HAND AND RECONSTRUCTIVE SURGERY, UNIVERSITY HOSPITAL GIESSEN GMBH IN GERMANY. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF HUMERAL FRACTURES WITH THE T2 HUMERAL NAILING SYSTEM¿ PUBLISHED ON JULY 8, 2021, WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 HUMERAL NAILING SYSTEM¿ SYSTEM. THIS REPORT INCLUDES RESEARCH DONE ON 81 PATIENTS BETWEEN THE PERIOD JANUARY, 2011 AND JANUARY, 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PROXIMAL CUT OUT FROM NAIL OVER HEALING TIME WHICH REQUIRED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253893 UNKNOWN T2 HUMERUS NAIL IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R