BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 95MM STERILE

    MDR report key: 7007248 · Received November 7, 2017

    Report

    Report Number
    3003506883-2017-10257
    Event Type
    Injury
    Date Received
    November 7, 2017
    Report Date
    October 13, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. (B)(4). DATE OF IMPLANT REPORTED AS EARLIER THIS YEAR (2017) COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICE THERAPY DATE REPORTED AS EARLIER THIS YEAR (2017) THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART # 04.038.295S LOT # H172887, RELEASE TO WAREHOUSE DATE: 19 SEPTEMBER 2016, EXPIRATION DATE: 31 AUGUST 2026, MANUFACTURING SITE: (B)(4). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 95 MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. 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. 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 UNDERWENT REVISION OF A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) IMPLANT ON (B)(6) 2017 DUE TO THE HELICAL BLADE FAILED FIXATION AND CUT OUT OF THE PATIENT'S RIGHT FEMORAL HEAD. THE IMPLANT WAS INITIALLY IMPLANTED EARLIER THIS YEAR ON AN UNKNOWN DATE. ALL THE REMOVED IMPLANTS WERE INTACT. THE PATIENT WAS REVISED TO A HEMIARTHROPLASTY. THERE WERE NO ISSUES DURING THE REVISION. THERE WAS NO REPORTED TIME DELAY OR PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: 12 MM 130 DEGREE TITANIUM CANNULATED TFNA 260 MM-RIGHT (04.037.256S, LOT H397872, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 95 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786364 TFNA HELICAL BLADE 95MM STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES ELMIRA H172887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL (04.037.256S, LOT H397872, QTY 1)