BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 85MM STERILE

    MDR report key: 7677635 · Received July 11, 2018

    Report

    Report Number
    2939274-2018-52806
    Event Type
    Injury
    Date Received
    July 11, 2018
    Report Date
    June 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982098979
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 04.038.285SS; LOT NUMBER: H191504; DATE OF MANUFACTURE: 10 FEBRUARY 2017; PLACE OF MANUFACTURE: (B)(4); PART EXPIRATION DATE: 31 JANUARY 2027; NONCONFORMANCE (NCR) NOTED. DESCRIPTION OF DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 85MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS BUT 1 NONCONFORMANCE WAS NOTED. NCR WAS WRITTEN FOR A COSMETIC CONCERN FOR DEBRIS/SPOTS ON THE PART SURFACE FOUND AT THE ANODIZE OPERATION. THE ENTIRE (B)(4) PIECE LOT WAS REWORKED FOR A RECLEANING OPERATION PRESCRIBED BY THE MATERIAL SCIENCE SME'S AND SUBSEQUENTLY INSPECTED. THE NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE COSMETIC ISSUES ALONE WOULD NOT CONTRIBUTE TO THE NEED FOR REVISION SURGERY. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL 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. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 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

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT ON (B)(6) 2018, DUE TO PAIN AND BREAST CANCER SPREADING TO THE PATIENT LEG. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL, TFNA HELICAL BLADE AND LOCKING SCREW ON AN UNKNOWN DATE A YEAR AGO. ALL IMPLANTS WERE REMOVED SUCCESSFULLY WITH NO ISSUES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521057 TFNA HELICAL BLADE 85MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.285S H191504 10886982098979

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention