BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE

    MDR report key: 10485219 · Received September 2, 2020

    Report

    Report Number
    8030965-2020-06568
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 1, 2020
    Report Date
    August 3, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    07611819199262
    PMA / PMN Number
    K040762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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 STERILE PART: PART: 04.004.543S, LOT: L212049, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: NOV. 29, 2016, EXPIRY DATE: NOV. 01, 2026. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED. NON-STERILE PART: PART: 04.004.543, LOT: L196286, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: NOV. 14, 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.

    Description of Event or Problem · 0

    ADDITIONAL EVENT INFORMATION : THE NAIL TIBIA HAS BEEN FINISHED WITHOUT ANY PARTICULAR PROBLEM FOR THE PATIENT SINCE IT IS THE PART USED FOR THE "IMPACTION" OF THE NAIL WHICH IS STUCK IN THE NAIL HOLDER.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J 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. 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 THAT ON (B)(6) 2020 DURING A TIBIAL NAIL PROCEDURE, THE CONNECTION PIECE FOR INSERTION GUIDE WAS JAMMED INSIDE THE NAILING HOOP. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED: UNKNOWN NAILS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949500 11MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE NAIL,FIXATION,BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH L212049 07611819199262

    Patients

    Seq Age Sex Outcome Treatment
    1 CONNEC L141 F/INSERTION HANDLE| INSERT-HANDLE F/EXPERT TN+FN