BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7 TI VA 1ST MTP FSN PL/SM/5 DG/R-S

    MDR report key: 18210324 · Received November 27, 2023

    Report

    Report Number
    8030965-2023-14852
    Event Type
    Injury
    Date Received
    November 27, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    10886982119568
    Adverse Event
    Yes
    Product Problem
    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. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODE: HWC. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6 PART: 04.211.232S; SYNTHES LOT:7873863; SUPPLIER LOT:N/A; RELEASE TO WAREHOUSE DATE: FEB 06, 2015; MANUFACTURED BY: SYNTHES ELMIRA; NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT THE SCREWS BROKE DURING THE REVISION SURGERY. THIS PC REPORTS THAT THE PLATE BREAKAGE, PAIN, AND FAULTY UNION OCCURRED AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE MTP FUSION PLATE FOR THE HALLUX VALGUS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PLATE BREAKAGE WAS CONFIRMED THREE MONTHS AFTER SURGERY. THEN, THE PATIENT WAS BEING FOLLOWED UP. HOWEVER, THE PATIENT COMPLAINED OF PAIN AND BONE FUSION HAS NOT BEEN ACHIEVED. THEREFORE, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.4/2.7 TI VA 1ST MTP FSN PL/SM/5 DG/R-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223119 2.4/2.7 TI VA 1ST MTP FSN PL/SM/5 DG/R-S PLATE, FIXATION, BONE HRS SYNTHES GMBH 7873863 10886982119568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - SCREWS: TRAUMA.