BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 75MM STERILE

    MDR report key: 11773028 · Received May 4, 2021

    Report

    Report Number
    8030965-2021-03560
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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: MAR 15, 2019. EXPIRATION DATE: MAR 01, 2029. PART NUMBER: 04.038.275S, TFNA HELICAL BLADE 75MM STERILE. LOT NUMBER: H843690 (STERILE). LOT QUANTITY: 48. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS NS072853 MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, FINAL INSPECTION, NS065693 MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 16090 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. DEVICE HISTORY REVIEW, (B)(6) 2021: DHR REVIEWED.

    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 SURGERY FOR PROXIMAL FEMORAL FRACTURE WITH THE BLADE IN QUESTION. AFTER THE SURGERY, ON UNKNOWN DATE, CUT-OUT OCCURRED AFTER NON-UNION. ON (B)(6) 2021, THE PATIENT WILL UNDERGO REVISION SURGERY USING JOINT DEVICES(S-ROM). NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TFNA HELICAL BLADE 75MM STERILE. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667115 TFNA HELICAL BLADE 75MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH H843690

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR