BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: NAIL DISTAL LOCKING

    MDR report key: 15816642 · Received November 17, 2022

    Report

    Report Number
    8030965-2022-09983
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    July 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS REPORT IS FOR ONE (1) UNK - SCREWS: NAIL DISTAL LOCKING, PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: 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: "OTHER AE RELATED TO THE PROCEDURE OR IMPLANT ¿ WOUND DISCHARGE" 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 ONE (1) UNK - SCREWS: NAIL DISTAL LOCKING. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HONG KONG AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2022 WITH THE PRODUCTS IN QUESTION. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT EXPERIENCED WOUND DISCHARGE AFTER SURGERY. THERE WAS NO INFECTION, AND THE PATIENT WAS GIVEN NON-OPERATIVE TREATMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837881 UNK - SCREWS: NAIL DISTAL LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention EXPERT TN Ø11 CANN L450 TAN LIGHT GREEN| UNK - SCREWS: NAIL PROXIMAL LOCKING