BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 15490657 · Received September 27, 2022

    Report

    Report Number
    8030965-2022-07363
    Event Type
    Injury
    Date Received
    September 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    10886982118998
    PMA / PMN Number
    K100776
    Adverse Event
    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. ADDITIONAL PROCODE:HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART # 04.211.014S. LOT # 8L27309. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 10 JUNE 2021. EXPIRATION DATE: 01 JUNE 2031. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG NON-STERILE PART # 04.211.014 NON-STERILE LOT # 128P682 MANUFACTURING SITE: 06 MAY 2021 RELEASE TO WAREHOUSE DATE: WERK SELZACH SUPPLIER: SYNTHES USA HQ, INC 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 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 JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304030 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 04.211.014 8L27309 10886982118998

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention