BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L42 TA

    MDR report key: 17187645 · Received June 22, 2023

    Report

    Report Number
    8030965-2023-07916
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 5, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819444270
    PMA / PMN Number
    K100776
    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: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 LOT: PART:04.211.042S. LOT:7L85177. MANUFACTURING SITE: WERK SELZACH. SUPPLIER:FRÜH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE:09 FEB 2021. EXPIRATION DATE: 01 FEB 2031. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 04.211.042. NON-STERILE LOT # 81P9436. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: SYNTHES USA HQ, INC. RELEASE TO WAREHOUSE DATE:09 DEC 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING DISTAL HUMERUS WITH THE SCREWS IN QUESTION ON (B)(6) 2021. AFTER SURGERY, ON (B)(6) 2023, A REMOVAL SURGERY WAS PERFORMED AS BONE FUSION WAS ACHIEVED. SURGEON CONFIRMED BY X-RAY, THAT THERE ARE NO PIECES IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ONE-TWENTY(120) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 42MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854409 VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L42 TA SCREW, FIXATION, BONE HWC SYNTHES GMBH 7L85177 07611819444270

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown UNK - EXTRACTION INSTRUMENTS: SHOULDER EXTRACTION| UNKNOWN DRILL BITS| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L34 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L46 TA