BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    MDR report key: 16453129 · Received February 28, 2023

    Report

    Report Number
    8030965-2023-02421
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 7, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334175892
    PMA / PMN Number
    K962616
    Product Problem
    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. ADDITIONAL NARRATIVE: PROCODE - HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. PMA/ 510(K) - K050110, K063049, K112583. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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: H6: DEVICE HISTORY RECORD )DHR) REVIEW CONDUCTED: PRODUCT CODE:402.884TS. LOT NO:485P647. MANUFACTURING SITE: JABIL GRENCHEN. RELEASE TO WAREHOUSE DATE: 22/11/2021. EXPIRY DATE:01/11/2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. 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. E1 E3: REPORTER IS A J&J SALES REPRESENTATIVE.

    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 AN UNKNOWN SURGERY WITH THE CORTEX SCREW IN QUESTION. VA CLAVICLE PLATE WAS USED ON THE PATIENT THREE WEEKS AFTER INJURY. AFTER FIXATION OF THE PLATE, THE IMAGE SHOWED FLEXURAL DISLOCATION OF THE SUPERIOR PROJECTION. THE CORTEX SCREW WAS INSERTED INTO THE PROXIMAL SCREW HOLE AND THE DISTAL SCREW HOLE FOR DRAWING IN THE BONE. THE CORTEX SCREW WAS BROKEN OFF UNDER THE SCREW HEAD. THE SURGEON DETERMINED THAT IT WAS DIFFICULT TO REMOVE THE BROKEN SCREW AND THE SCREW SHAFT REMAINED IN THE BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. ACCORDING TO THE SURGEON, THE PATIENT IS YOUNG, AND THE BREAKAGE WAS CAUSED BY FORCEFUL INSERTION IN AN ATTEMPT TO PULL IT IN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388010 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 485P647 07612334175892

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male UNK - PLATES: CLAVICLE