BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELBOW HINGE FIXATOR

    MDR report key: 12018496 · Received June 17, 2021

    Report

    Report Number
    8030965-2021-05044
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    May 24, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819815070
    PMA / PMN Number
    K063832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: LXT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR RADIUS HEAD FRACTURE WITH ELBOW HINGE FIXATOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT PROLONGATION. AFTER THE SURGERY, ON MAY 22, WHEN THE PATIENT STARTED ROM EXERCISE, THE METAL PART OF THE HINGED JOINT ROD CAME OFF. AS A RESULT, THE HINGED JOINT ROD BECAME NON-FUNCTIONAL. THIS REPORT IS FOR ONE (1) ELBOW HINGE FIXATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911780 ELBOW HINGE FIXATOR APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 07611819815070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention