BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA HELICAL BLADE 100MM

    MDR report key: 7425848 · Received April 12, 2018

    Report

    Report Number
    2939274-2018-51620
    Event Type
    Injury
    Date Received
    April 12, 2018
    Report Date
    March 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982099020
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, DATE OF BIRTH, GENDER, AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE CUT OUT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.038.300S, LOT# H183655. MANUFACTURING LOCATION: ELMIRA, MANUFACTURING DATE: SEP 29, 2016, EXPIRY DATE: AUG 31, 2026. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA HELICAL BLADE 100MM 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 PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, HELICAL BLADE, AND 5.0 MM LOCKING SCREW ON (B)(6) 2018. ON UNKNOWN DATE AN ANTERIOR CUTOUT OF THE HELICAL BLADE AND FEMORAL HEAD COLLAPSE WERE DETECTED. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO A HIP ARTHROPLASTY. CONCOMITANT DEVICES REPORTED: 12 MM 130 DEGREE TITANIUM CANNULATED TFNA NAIL 170 MM (04.037.242S, LOT H464168, QUANTITY 1), 5.0 MM LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 100 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269078 TFNA HELICAL BLADE 100MM ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.300 H183655 10886982099020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention