BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP, SCN T2 SCN

    MDR report key: 11949734 · Received June 7, 2021

    Report

    Report Number
    0009610622-2021-00538
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    August 13, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540378613
    PMA / PMN Number
    K023267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED AND NO OTHER EVIDENCE WAS PROVIDED FOR EVALUATION. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED AND NO OTHER EVIDENCE WAS PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE INFORMATION AS WELL AS THE DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED: "DOCTOR SENT AN X-RAY SHOWING THAT THE T2 SCN END CAP WAS OUT OF THE NAIL AND IN THE PATIENT'S JOINT. THE REPORTER IS UNAWARE IF A REVISION IS SCHEDULED TO HAPPEN".

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED: "DOCTOR SENT AN X-RAY SHOWING THAT THE T2 SCN END CAP WAS OUT OF THE NAIL AND IN THE PATIENT'S JOINT. THE REPORTER IS UNAWARE IF A REVISION IS SCHEDULED TO HAPPEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844979 END CAP, SCN T2 SCN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 1826-0003S K0E60FC 04546540378613

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR