BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE

    MDR report key: 8232943 · Received January 10, 2019

    Report

    Report Number
    8030965-2019-59690
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819651098
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. REPORTER CONTACT NUMBER. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 04.037.227S, LOT: 9963039. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: FEB 29, 2016, EXPIRY DATE: FEB 28, 2026. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 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. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES SALES CONSULTANT. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 ON AN UNKNOWN DATE, A SHORT NAIL (NOT DEPUY SYNTHES PRODUCT) WAS IMPLANTED TO THE PATIENT. AFTER THE SURGERY, THE PATIENT HAD FRACTURE AROUND DISTAL END OF THE NAIL. ON (B)(6) 2018, RE-OPERATION TO REMOVE THE NAIL AND IMPLANTATION OF TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM WAS PERFORMED. DURING SURGERY, AN END CAP 0MM WAS INSERTED BEFORE DISTAL SIDE STOPPING BECAUSE SOME DEVICES FOR DISTAL SIDE STOPPING HAD NOT BEEN STERILIZED YET. WHEN THE SURGEON TRIED TO FASTEN THE END CAP, IT COULD NOT BE TIGHTENED, AND IT KEPT ROTATING ON THE NAIL. THEN, THE LOCKING MECHANISM IN THE NAIL WAS RE-ENGAGED, AND RE-TRIED TO TIGHTEN THE END CAP. HOWEVER, THE SAME PROBLEM OCCURRED. THE END CAP WAS REPLACED TO AN END CAP 5MM, HOWEVER, THE SAME PROBLEM OCCURRED. WHILE THE SURGEON TRIED TO REPEAT INSERTION OF THE END CAP AND RE-ENGAGEMENT OF THE LOCKING MECHANISM, STERILIZATION OF DEVICES FOR DISTAL SIDE STOPPING WAS FINISHED. THUS, DISTAL SIDE STOPPING WAS PERFORMED. THE SURGEON CHECKED THE CONDITION OF LOCKING MECHANISM IN THE NAIL WITH THE BLADE AND TRIED TO CONNECT AN INSERTION HANDLE TO THE NAIL. HOWEVER, SURGEON COULD NOT DO IT SUCCESSFULLY. THEN, THE SURGEON TRIED TO CONNECT THE INSERTOR TO THE BLADE. AT THIS TIME, THE NAIL SHIFTED TO LATERAL SIDE OF THE BONE, AND THE BLADE WAS PUSHED BY THE INSERTOR TO THE MEDIAL SIDE. THUS, THE BLADE ADVANCED DEEPER IN THE BONE, AND THE EDGE OF THE BLADE SLIPPED FROM SURFACE OF THE CORTICAL BONE. DUE TO THIS, A PART OF THE CORTICAL BONE WAS CAUGHT BETWEEN THE BLADE AND THE INSERTOR, AND THE CORTICAL BONE PREVENTED THE INSERTOR FROM CONTACTING THE BLADE. HE THEN SHAVED THE CORTICAL BONE AND PULLED BACKED THE BLADE. SURGEON THEN, CHECKED THE ROTATION POSITION OF THE BLADE AND RE-ENGAGED THE LOCKING MECHANISM. FINALLY SUCCEEDED IN INSERTING AND TIGHTENING THE END CAP. SURGEON COMMENTED THAT WHILE REPLACING THE NAILS, REDUCTION OF THE AFFECTED SITE WAS NOT KEPT PROPERLY. THUS, CONDITION OF THE PIECES OF THE BONE WAS UNSTABLE. THE SURGEON COULD NOT FEEL THE WHETHER THE LOCKING MECHANISM WAS ENGAGED PROPERLY OR NOT USING FLEXIBLE SCREW DRIVER. THUS, COMPLAINED OF THE FLEXIBLE SCREW DRIVER ABOUT THIS POINT. THERE WAS A SURGICAL DELAY OF 90 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26362 12MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9963039 07611819651098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention