BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    MDR report key: 9538333 · Received January 2, 2020

    Report

    Report Number
    8030965-2020-00008
    Event Type
    Injury
    Date Received
    January 2, 2020
    Report Date
    December 8, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    PMA / PMN Number
    K953644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. WE RECEIVED BACK THE PART IN A USED CONDITION. FURTHERMORE, THE CORRESPONDING BIOLOGICAL SAFETY EVALUATION VERIFIES THAT THE USED MATERIAL IS BIOCOMPATIBLE. IN CONCLUSION, THE COMPLAINT DOES NOT IMPLICATE A DESIGN RELATED ISSUE NOR DOES IT CREATE ANY ADDITIONAL RISK TO THE PATIENT. NO FURTHER ACTIONS REQUIRED FROM A PRODUCT DEVELOPMENT PERSPECTIVE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT , PART NUMBER: 401.762, SYNTHES LOT NUMBER: L243946, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 22. DEC. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT HAS DEVELOPED SKIN RASH AROUND THE IMPLANT ZONE AFTER TWO YEARS OF IMPLANTATION. THE SKIN BIOPSY WAS SUGGESTIVE OF VASCULITIS LINED TO METAL REACTION- ORIF OF WRIST (DISTAL RADIUS)LT. THE PATIENT IS SCHEDULED FOR REVISION SURGERY FOR HARDWARE REMOVAL. THERE WOULD BE 1 PLATE AND 6 SCREWS ARE INVOLVED. PATIENT CONDITION WAS UNKNOWN. THIS IS REPORT 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3517 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L243946

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention