BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT/STERILE

    MDR report key: 23694246 · Received December 2, 2025

    Report

    Report Number
    8030965-2025-12008
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07612334218544
    PMA / PMN Number
    K210207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, 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 ==> A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT: 72568P0, ARTICLE: 02.221.100S, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 11/20/2025: DHR/SHR REVIEW FOR THE FOLLOWING DEVICE CONDUCTED: PRODUCT CODE: 02.221.100S, LOT NUMBER: 72568P0, MANUFACTURING DATE: 07/23/2025, EXPIRY DATE: 07/01/2035, NO NON-CONFORMANCE / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, AFTER TEMPLATING THE CORRECT SIZE OF PPFX PLATE AND PPFX GT RING THE STERILE IMPLANTS WERE OPENED AND THE SCRUB NURSE ATTEMPTED TO JOIN THE GT RING TO THE PPFX PLATE USING THE APPROPRIATE SCREW DRIVER AND INTERLOCKING THE RING WITH THE PLATE. NURSE WAS UNSUCCESSFUL IN OBTAINING CORRECT INTERFACE BETWEEN THE TWO IMPLANTS WHILE SCREWING IN THE CONNECTION SCREW ON NUMEROUS OCCASIONS. SURGEON ALSO ATTEMPTED TO CONNECT THE TWO IMPLANTS TOGETHER BUT WAS SOON REALIZED THAT THE THREADS ON THE CONNECTION SCREW ATTACHED TO THE GT RING WERE DAMAGED. A SECOND GT RING WAS OPENED AND NUMEROUS ATTEMPTS WERE MADE AGAIN TO JOIN THE TWO TOGETHER, ALL WITH NO LUCK. AT THIS POINT A SECOND PLATE WAS OPENED AS WELL TO SEE IF THE PROBLEM WAS WITH THE PLATE OR THE GT RING, HOWEVER THE CONNECTION BETWEEN TWO IMPLANTS FAILED AGAIN. AT THIS POINT THE USE OF THE GT RING WAS GIVEN UP AND THE PROCEDURE WENT AHEAD SUCCESSFULLY WITHOUT THE ATTACHMENT. THE EVENT LED TO A SURGICAL DELAY OF AT LEAST 30-45 MINUTES, BUT THERE WAS NO CONSEQUENCE TO THE PATIENT. THE SALES REPRESENTATIVE WAS LATER INFORMED THAT IF THE SCREW THREADS ON THE GT RING ARE DAMAGED DURING ASSEMBLY WITH THE PPFX PLATE, BOTH THE GT RING AND THE PPFX PLATE MUST BE REPLACED, SINCE THE PLATE¿S LOCKING THREADS WILL ALSO BE COMPROMISED AND REPLACING ONLY THE GT RING WILL NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50321 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT/STERILE PLATE, FIXATION, BONE HRS SYNTHES GMBH 72568P0 07612334218544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown