BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUN TIBIA Ø10 L345 SST

    MDR report key: 8370923 · Received February 26, 2019

    Report

    Report Number
    8030965-2019-61438
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    January 30, 2019
    Report Date
    January 31, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDS
    UDI-DI
    07611819207400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER

    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. ACCORDING TO THE PICTURES, IT CAN BE CONFIRMED THAT THE NAILS ARE DAMAGED/DEFORMED. DEVICE HISTORY LOT. PART: 256.034. LOT: 8221751. MANUFACTURING SITE: BETTALCH. RELEASE TO WAREHOUSE DATE: 18.DECEMBER 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 8221751, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL DATA: B3, B5, D11 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

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE SIMPLIFIED UNIVERSAL NAIL (SUN) FOR TIBIA AND AN UNKNOWN TIBIAL NAIL WERE DEFORMED JUST AFTER BEING PLACED AND HAMMERED. ANOTHER UNIVERSAL TIBIAL NAIL WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE PATIENT OUTCOME AFTER THE PROCEDURE WAS VERY GOOD.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN TRAUMA PROCEDURE AT (B)(6) ON (B)(6) 2019, TWO (2) SIMPLIFIED UNIVERSAL NAIL (SUN) FOR TIBIA WERE DEFORMED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A SUN TIBIAL NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165134 SUN TIBIA Ø10 L345 SST NAIL, FIXATION, BONE JDS OBERDORF SYNTHES PRODUKTIONS GMBH 8221751 07611819207400

    Patients

    Seq Age Sex Outcome Treatment
    1