BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE

    MDR report key: 8624097 · Received May 20, 2019

    Report

    Report Number
    8030965-2019-64168
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    April 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089816
    PMA / PMN Number
    K172872
    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. 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. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD, DEVICE HISTORY LOT PART: 04.168.275S, LOT: L998462, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 02.AUGUST 2018, EXPIRY DATE: 01.JULY 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DATE OF REPORT: IT WAS REPORT THAT THE ALERT DATE IS APRIL 21, 2019 DUE TO TIME ZONE DIFFERENCE. 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

    UPDATED: CONCOMITANT DEVICES REPORTED: PLATE FOR FNS (PART # 04.168.000S, LOT # 694717, QUANTITY 1) LOCKING SCREW STARDRIVE (PART # 412.214S, LOT # 791130, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. (B)(4). 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 ON (B)(6) 2019, AN IMPLANT CUT-OUT WAS CONFIRMED. INITIALLY, THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY USING THE FEMORAL NECK SYSTEM (FNS) FOR A FEMORAL NECK FRACTURE ON (B)(6) 2018. HOWEVER, FOLLOWING THE SURGERY, THE BONE HEAD GRADUALLY ROTATED AND SLID. THE HOSPITAL TRIED THE PATIENT FOR NON-WEIGHT BEARING ACTIVITIES, BUT THE IMPLANT CUT-OUT WAS CONFIRMED. THE HOSPITAL PLANNED FOR A RE-OPERATION ON AN UNKNOWN DATE, IN WHICH THE IMPLANTS WILL BE REPLACED WITH AN ARTIFICIAL BONE HEAD. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416720 BOLT FOR FEMORAL NECK SYSTEM 75MM LENGTH - STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L998462 07612334089816

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention LOCKSCR Ø5 SELF-TAP L40 TAN| PL 1-HO F/FEM NECK SYST TAN