BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE L85 TAN

    MDR report key: 11585972 · Received March 29, 2021

    Report

    Report Number
    8030965-2021-02417
    Event Type
    Injury
    Date Received
    March 29, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819652439
    PMA / PMN Number
    K131548
    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. 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 PART NUMBER: 04.038.285S, LOT NUMBER: H771691, PART MANUFACTURING DATE: 16 NOVEMBER 2018, MANUFACTURING SITE: ELMIRA, PART EXPIRATION DATE: 01 NOVEMBER 2028, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H771691 OF TFNA HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT H653777 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE 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. THE SURGEON COMMENTED THAT THE PROXIMAL BONE FRAGMENT COULD NOT BE CHANGED TO THE EXTRAMEDULLARY TYPE, AND NO CONTACT BETWEEN THE BONE FRAGMENTS WAS OBTAINED. THE PROXIMAL BONE FRAGMENT HIT THE NAIL AND THE BLADE SLIDING STOPPED. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1)TFNA HELICAL BLADE L85 TAN THIS REPORT IS 1 OF 2 (B)(4). THIS PC RELATED TO (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482394 TFNA HELICAL BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH H771691 07611819652439

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention TFNA HELICAL BLADE L85 TAN| UNK - SCREWS: LOCKING