BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 85MM STERILE

    MDR report key: 11585779 · Received March 29, 2021

    Report

    Report Number
    8030965-2021-02415
    Event Type
    Injury
    Date Received
    March 29, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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 LOT: MANUFACTURING LOCATION: ELMIRA / MONUMENT, MANUFACTURING DATE: 16-NOV-2018, EXPIRATION DATE: 01-NOV-2028, PART NUMBER: 04.038.285S, TFNA HELICAL BLADE 85MM -STERILE, LOT NUMBER: H771691 (STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART. INSPECTION SHEET, NS072853 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, FINAL INSPECTION, NS065693 REV R MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AC WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 15698 SUPPLIED BY STERIGENICS WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿REMOVAL DUE TO NON-UNION AND CUT-OUT¿ DOES NOT INDICATE BREAKAGE OF THE BLADE. THEREFORE, REVIEW OF THE RAW MATERIAL WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. DEVICE HISTORY REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT 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 · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE WITH THE TFNA NAIL AND BLADE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. 1 WEEK AFTER THE SURGERY, IT WAS CONFIRMED THAT THE BLADE SLID ABOUT 10 MM AND THE SLIDING STOPPED WHEN THE PROXIMAL BONE FRAGMENT TOUCHED THE NAIL. ON (B)(6) 2021, THE PATIENT VISITED THE HOSPITAL. ON THE SAME DAY, IT WAS CONFIRMED BY X-RAYS THAT NON-UNION AND SLIGHT CUT-OUT HAD OCCURRED. ON (B)(6), THE PATIENT WILL UNDERGO THE REVISION SURGERY REMOVING THE TFNA IMPLANTS AND PERFORMING BHA SURGERY. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED. UNKNOWN LOCKING SCREWS TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TFNA HELICAL BLADE 85MM STERILE. THIS REPORT IS 2 OF 2 (B)(4). THIS PC RELATED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482182 TFNA HELICAL BLADE 85MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH H771691

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention TFNA FEM NAIL Ø11 LE 125° L320 TIMO15| UNK - SCREWS: LOCKING