BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 90MM STERILE

    MDR report key: 18819621 · Received March 1, 2024

    Report

    Report Number
    8030965-2024-03105
    Event Type
    Injury
    Date Received
    March 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819652446
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 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 REVIEW (DHR): PART # 04.038.290S, SYNTHES LOT # H191496, SUPPLIERS LOT # NA, RELEASE TO WAREHOUSE DATE: 13 OCT 2016, MANUFACTURED BY: SYNTHES ELMIRA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J SALES REPRESENTATIVE. 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 · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A FEMORAL FRACTURE. AFTER THE SURGERY, THE TIP OF THE BLADE CUT THROUGH THE BONE HEAD AND A REVISION SURGERY VIA AN ARTIFICIAL BONE HEAD REPLACEMENT WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2024. PATIENT OUTCOME IS REPORTED AS STABLE. SURGEON COMMENTED THAT DURING INSERTION OF THE BLADE IN THE INITIAL SURGERY, THE LONG BLADE WAS INSERTED JUST TO THE EDGE OF THE CORTICAL BONE OF THE BONE HEAD, WHICH CAUSED THE BLADE TO CUT THROUGH WHEN A SLIGHT SLIDING OCCURRED DURING THE FUSION PROCESS, LEADING TO PAIN FOR THE PATIENT. IT WAS ALSO REPORTED THAT THE PATIENT'S BONE QUALITY IS NOT VERY GOOD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 90MM STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290256 TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH H191496 07611819652446

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention