BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM

    MDR report key: 20200601 · Received September 12, 2024

    Report

    Report Number
    8030965-2024-11300
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 12, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819444195
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: 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 (DHR): PART # 04.211.026TS LOT # 8L90448 MANUFACTURING SITE: (B)(6) RELEASE TO WAREHOUSE DATE: 15 DEC 2021 EXPIRATION DATE: 01 DEC 2026 SUPPLIER: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. ------------------------------------------------- NON-STERILE PART # 04.211.026 NON-STERILE LOT # 468P450 MANUFACTURING SITE: WERK SELZACH LOGISTIK RELEASE TO WAREHOUSE DATE: 03 NOV 2021 SUPPLIER: SYNTHES USA HQ, INC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED 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

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION WITH THE PLATE AND THE LOCKING SCREWS FOR A CLAVICLE DIAPHYSEAL FRACTURE. FOUR CORTICAL SCREWS WERE INSERTED ANTERIORLY, AND FOUR SCREWS EACH WERE INSERTED INTO THE LATERAL SCREW HOLES AND INTERNAL SCREW HOLES OF THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON AUGUST 12, 2024, IT WAS CONFIRMED THAT ALL THE INTERNAL FOUR SCREWS WERE BROKEN OFF. A REMOVAL SURGERY WAS SCHEDULED FOR (B)(6), 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556782 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 26MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 8L90448 07611819444195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention VA-LCP CLAVIC PL 2.7 SHAFT CS3 LE TAN