BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PL 1-HO F/FEM NECK SYST TAN

    MDR report key: 17157065 · Received June 19, 2023

    Report

    Report Number
    8030965-2023-07651
    Event Type
    Injury
    Date Received
    June 19, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089687
    PMA / PMN Number
    K172872
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 04.168.000S. LOT NUMBER: 1841P66. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 14/09/2022 . MANUFACTURING SITE: JABIL GRENCHEN. EXPIRY DATE: 01/09/2032 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 DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL NECK FRACTURE WITH FNS PLATE, BOLT, ANTIROTATION SCREW AND LOCKING SCREWS. POSTOPERATIVELY, THERE WERE REPORTS OF SECONDARY FRACTURE FAILURES DISTAL TO THE PLATE. THE SURGEON'S COMMENTED THAT THE PATIENT FELL AFTER FNS SURGERY AND THE STRESS WAS CONCENTRATED IN THE DISTAL PART OF THE PLATE, RESULTING IN A SECONDARY FRACTURE AND NOT DUE TO PRODUCTS. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747702 PL 1-HO F/FEM NECK SYST TAN APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 1841P66 07612334089687

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L.| BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH.| LOCKSCR Ø5 SELF-TAP L42 TAN.