BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE

    MDR report key: 18503993 · Received January 12, 2024

    Report

    Report Number
    8030965-2024-00793
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    November 14, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    10886982083616
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. E1: (B)(6). 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.

    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 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

    PATIENT CONSEQUENCES WERE REPORTED AS PROLONGED HOSPITALIZATION, ANTIBIOTICS AND WOUND DRESSINGS, PATIENT RECOVERED WITHOUT PERSISTENT DAMAGE.

    Description of Event or Problem · 0

    THE SITE HOQ (HONG KONG) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT (B)(6). AE1: POSTOPERATIVE ADVERSE EVENT: "FRACTURE-RELATED INFECTION (FRI)" IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES" IS THE AE RELATED TO THE DEVICE? "POSSIBLE" DPS IMPLANT WAS USED. THIS REPORT IS FOR AN 8MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818316 8MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES GMBH 10886982083616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention EXPERT TIBIAL NAIL PROTECT Ø8 CANN L315| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL PROXIMAL LOCKING