BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE

    MDR report key: 10088372 · Received May 26, 2020

    Report

    Report Number
    8030965-2020-03697
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 12, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07612334089830
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.168.285S, LOT: 30P2313, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 09 DEZ. 2019, EXPIRY DATE: 01. NOV. 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH LOT NUMBER 30P2313, 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.

    Additional Manufacturer Narrative · 1

    EVENT YEAR REPORTED AS 2020, EXACT DATE OF POSTOPERATIVE MIGRATION IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. (B)(4). 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, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR FEMORAL NECK FRACTURE WITH A FEMORAL NAIL SYSTEM (FNS). ON MAY 11, THE PATIENT VISITED THE HOSPITAL AND THE SURGEON CONFIRMED THAT THE CUT-OUT OCCURRED AT THE BONE HEAD. THE PATIENT HAD PAIN WHEN WALKED. ON (B)(6) 2020, THE PATIENT UNDERWENT THE REMOVAL OF THE FNS AND BIPOLAR HEMI-ARTHROPLASTY (BHA) SURGERY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE-STERILE (PART # 04.168.000S, LOT # 5L65404, QUANTITY 1); ANTI-ROTATION SCREW FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE (PART # 04.168.485S, LOT # 19P4962, QUANTITY 1); 5.0MM TI LOCKING SCREW SELF TAPPING WITH T25 STARDRIVE 42MM-STERILE (PART # 412.215S, LOT # 6L51052, QUANTITY 1). THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549915 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 30P2313 07612334089830

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L| LOCKSCR Ø5 SELF-TAP L42 TAN| PL 1-HO F/FEM NECK SYST TAN