BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE

    MDR report key: 17760119 · Received September 15, 2023

    Report

    Report Number
    8030965-2023-11672
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089847
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B3: ONLY THE EVENT YEAR IS KNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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: 04.168.290S. LOT NUMBER : 3190P38. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 24/11/2022. MANUFACTURING SITE: (B)(4). 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 SURGERY WITH THE IMPLANTS IN QUESTION FOR FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON AN UNKNOWN DATE, A SUBCONDYLAR FRACTURE OCCURRED AT THE SCREW PORTION OF THE PLATE WHEN THE PATIENT MADE A TURNING MOTION, SUCH AS LOOKING BACK. ON (B)(6) 2023, THE REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS FOR FEMORAL NECK SYSTEM AND RE-FIXED WITH THE OTHER COMPANY¿S IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THE SURGEON SUGGESTED THAT THE SCREWS IN THE PLATE WERE SLIGHTLY ANTERIOR, AND THAT THE POSTOPERATIVE TURNING MOTION CAUSED THE FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041030 BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 3190P38 07612334089847

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L| LOCKSCR Ø5 SELF-TAP L44 TAN| PL 1-HO F/FEM NECK SYST TAN