BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE

    MDR report key: 11257850 · Received February 1, 2021

    Report

    Report Number
    8030965-2021-00743
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 11, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089847
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. PART: 04.168.290S, LOT: L873530, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: APRIL 25, 2018, EXPIRY DATE: APRIL 1, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. HEALTH EFFECT CLINICIAN CODE (B)(4) USED TO CAPTURE INJURY. 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 ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE FEMORAL NECK FRACTURE WITH THE FNS BOLT. DURING THE MEASURE, THE MEASURE VALUE OF THE BOLT WAS 90MM. THE SURGEON INSERTED THE 90MM BOLT, BUT THE BOLT WAS TOO LONG. THE SURGEON REPLACED THE 90MM BOLT WITH AN 85MM BOLT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154901 BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH L873530 07612334089847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention