BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL

    MDR report key: 18276278 · Received December 6, 2023

    Report

    Report Number
    8030965-2023-15424
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 14, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089953
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL CENTER FOUNDATION 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 (DHR): A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE#:04.168.485S. LOT #:3189P20. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 28/11/2022. MANUFACTURING SITE: JABIL GRENCHEN. EXPIRY DATE: 01/11/2032. 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 WITH THE FNS (FEMORAL NECK SYSTEM) FOR A RIGHT FEMORAL NECK FRACTURE. ON (B)(6) 2023, THE PATIENT FELL, AND AN X-RAY SHOWED THAT CUTOUT OCCURRED. THEREFORE, A THA (TOTAL HIP ARTHROPLASTY) REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179848 ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 3189P20 07612334089953

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH| LOCKSCR Ø5 SELF-TAP L38 TAN| PL 1-HO F/FEM NECK SYST TAN