BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL

    MDR report key: 17468944 · Received August 7, 2023

    Report

    Report Number
    8030965-2023-09910
    Event Type
    Injury
    Date Received
    August 7, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089946
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: INITIAL REPORTER FACILITY ADDRESS: (B)(6) HOSPITAL. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: 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. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE#:04.168.480S, LOT #:4526P57. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 20/02/2023, MANUFACTURING SITE: JABIL GRENCHEN, EXPIRY DATE:01/02/2033. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A FEMORAL NECK FRACTURE WITH THE FNS PLATE, BOLT, AND ANTIROTATION SCREW. ON (B)(6) 2023, THE PATIENT WAS READMITTED FOR A SUBTROCHANTERIC FRACTURE. ON (B)(6) 2023, A REOPERATION WAS PERFORMED, AND T2 WAS INSERTED. THE PATIENT APPEARED TO HAVE FALLEN SEVERAL TIMES DUE TO SEVERE DEMENTIA. THE DATE OF THE FALL IS UNKNOWN. NO ABNORMALITIES WERE FOUND IN THE PATIENT¿S BONES BETWEEN THE INITIAL SURGERY AND DISCHARGE FROM THE HOSPITAL. THIS REPORT INVOLVES ONE ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637590 ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM LENGTH - STERIL APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 4526P57 07612334089946

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH| LOCKSCR Ø5 SELF-TAP L34 TAN| PL 1-HO F/FEM NECK SYST TAN