BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE

    MDR report key: 10009536 · Received April 29, 2020

    Report

    Report Number
    8030965-2020-03180
    Event Type
    Injury
    Date Received
    April 29, 2020
    Report Date
    April 13, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089687
    PMA / PMN Number
    K172872
    Adverse Event
    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. H4, H6: PART: 04.168.000S, LOT: L872986, MANUFACTURING SITE: GRENCHEN. RELEASE TO WAREHOUSE DATE: 26.APR.2018, EXPIRY DATE: 01.APR.2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RECEIVED X-RAYS WERE REVIEWED AND THE BONE FRACTURE IN THE AREA OF THE LOCKING SCREW IS VISIBLE, THEREFORE THE COMPLAINT IS RATED AS CONFIRMED. DURING THE REVIEW NO MALFUNCTION LIKE CUT/BACK OUT, LOOSENING OR BREAKAGE OF THE IMPLANTS COULD BE DETECTED. PRODUCTS WERE NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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.

    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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A PATIENT HAD POST OP FEMORAL NECK FRACTURES. THE FIRST SURGERY USING THE FEMORAL NECK SYSTEM (FNS) WAS PERFORMED ON (B)(6) 2018, FOR THE PATIENT¿S LEFT FEMORAL NECK FRACTURE. THE FIXATION WITH FNS WAS PERFORMED CORRECTLY. ON (B)(6) 2020, THE PATIENT HAD A PAIN AT UPPER LEG AND BY X-RAY, FRACTURES WERE CONFIRMED AROUND THE END OF THE LOCKING SCREW. THE SURGEON JUDGED THE FEMORAL NECK FRACTURE WAS NOT HEALED AND DIAGNOSED AS IPSILATERAL FEMORAL FRACTURE. ON (B)(6) 2020, OPEN REDUCTION INTERNAL FIXATION SURGERY WAS PERFORMED FOR THE PATIENT¿S IPSILATERAL FEMORAL FRACTURE WITH EXPERT AFN. DURING THE SURGERY, THE SURGEON FIXED THE FRACTURES WITH AFN AFTER REMOVING FNS DEVICES AND FILLED BONE HEAD AND BONE DEFECT WITH BONE CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON NOTED THAT THE STRESS WAS CENTERED AT THE END OF THE FNS PLATE, WHEN HE OBSERVED THE PATIENT¿S BONE WHICH WAS REMOVED FNS DEVICES DURING THE SURGERY. CONCOMITANT DEVICES REPORTED: BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE (PART NUMBER 04.168.285S, LOT L874470, QUANTITY 1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH ¿ STERILE (PART NUMBER 04.168.485S, LOT L883389, QUANTITY 1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE (PART NUMBER 412.212S, LOT L718211, QUANTITY 1). THIS REPORT INVOLVES ONE (1) FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474944 FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L872986 07612334089687

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 5.0MM TI LOCKING SCR| 5.0MM TI LOCKING SCR| ANTIROTATION SCR FOR FEM NECK SYS| ANTIROTATION SCR FOR FEM NECK SYS| BOLT FOR FEMORAL NECK SYS| BOLT FOR FEMORAL NECK SYS