BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE

    MDR report key: 9968658 · Received April 16, 2020

    Report

    Report Number
    8030965-2020-02881
    Event Type
    Injury
    Date Received
    April 16, 2020
    Report Date
    March 24, 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. CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. 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. INVESTIGATION SUMMARY. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY. STERILE - PART. PART: 04.168.285S. LOT: L873526. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 26. APRIL 2018. EXPIRY DATE: 01. APRIL 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON STERILE-PART. PART: 60123907. LOT: L704168. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 10. APRIL 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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.

    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) 2019, THE PATIENT FRACTURED HIS RIGHT MEDIAL FEMORAL NECK BONE. THE PATIENT WAITED DUE TO THE CONTROL OF DIABETES MELLITUS, AND ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY WITH THE FEMORAL NECK SYSTEM (FNS). THERE WAS NO SURGICAL DELAY. SIX (6) WEEKS POSTOPERATIVELY, THE PATIENT HAD NO WEIGHT BEARING, AND THE HOSPITAL CONFIRMED THAT THERE WAS NO PROBLEM. AFTER THAT, THE PATIENT DIDN¿T VISIT THE HOSPITAL AND THE HOSPITAL COULDN¿T FOLLOW UP. ON (B)(6) 2020, THE PATIENT VISITED ANOTHER HOSPITAL AND REPORTED PAIN. THE HOSPITAL CONFIRMED THAT MIGRATION OF DEVICES. REVISION SURGERY WAS SCHEDULED FOR (B)(6), AND THE PATIENT WILL BE REVISED TO A TOTAL HIP. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433830 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L873526 07612334089830

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L| ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L| LOCKSCR Ø5 SELF-TAP L42 TAN| LOCKSCR Ø5 SELF-TAP L42 TAN| PL 1-HO F/FEM NECK SYST TAN| PL 1-HO F/FEM NECK SYST TAN