BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE

    MDR report key: 16489012 · Received March 6, 2023

    Report

    Report Number
    8030965-2023-02718
    Event Type
    Injury
    Date Received
    March 6, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089823
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H10 ADDITIONAL NARRATIVE: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND NO NON-CONFORMANCE WAS IDENTIFIED. PRODUCT CODE: 04.168.280S. LOT NUMBER: 44P3589. MANUFACTURING SITE: JABIL GRENCHEN. RELEASE TO WAREHOUSE DATE:04/03/2020. EXPIRY DATE:01/02/2030. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE ADVERSE EVENT MENTIONED ON THE EVENT DESCRIPTION CANNOT BE CONFIRMED DUE TO NO FURTHER EVIDENCE WAS PROVIDED. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH [04.168.280S/44P3589]. THROUGH FOLLOW UP THERE IS NO ALLEGATION ASSOCIATED WITH THIS PRODUCT. NO VISIBLE DAMAGE WAS FOUND DURING THE INVESTIGATION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THERE IS NO ALLEGATION ASSOCIATED WITH THIS BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH [04.168.280S/44P3589]. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. 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.

    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. H10 ADDITIONAL NARRATIVE: H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 4, 2020, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A FEMORAL NECK FRACTURE WITH THE PRODUCTS IN QUESTION. AFTER APPROXIMATELY 2 YEARS, OSTEOCLAVICULAR NECROSIS OCCURRED, AND SURGERY WAS PERFORMED ON (B)(6) 2023 TO REPLACE THE THA AFTER REMOVAL OF THE FNS. IT IS THE PHYSICIAN'S VIEW THAT THIS IS A POSSIBLE COMPLICATION OF FEMORAL NECK FRACTURES, WHICH CAN OCCUR WHEN THE FRACTURE LOCATION AND FRACTURE TYPE AFFECT BLOOD FLOW. THE BASIC IDEA IS THAT THE OUTCOME IS ALMOST ALWAYS DETERMINED AT THE TIME OF INJURY, RATHER THAN THE SURGICAL APPROACH OR THE IMPLANTS USED, AND HE BELIEVE THAT THERE IS ALMOST NO CAUSAL RELATIONSHIP WITH FNS. THE PHYSICIAN CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT AFTER SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS REPORT IS RELATED TO (B)(4) WHICH REPORTS DIFFICULTY IN REMOVAL. THIS PC REPORTS THE ONSET OF OSTEONECROSIS. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549581 BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 44P3589 07612334089823

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L| LOCKSCR Ø5 SELF-TAP L40 TAN| PL 1-HO F/FEM NECK SYST TAN