BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 9661559 · Received February 3, 2020

    Report

    Report Number
    2939274-2020-00617
    Event Type
    Injury
    Date Received
    February 3, 2020
    Report Date
    January 13, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982226716
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. PART NUMBER: 456.305, LOT NUMBER: 6191314, PART MANUFACTURE DATE: N/A, MANUFACTURING LOCATION: N/A, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED AND THE LOT NUMBER PROVIDED DOES NOT MATCH THE PART NUMBER. 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. (B)(4). 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 ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF BILATERAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAILS IN BOTH RIGHT AND LEFT LEGS DUE TO NON-UNION AND INFECTION. FOR THE RIGHT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) HELICAL BLADE, AND TWO (2) UNKNOWN 5.0MM SCREWS WERE REMOVED. FOR THE LEFT LEG, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL, ONE (1) END CAP, ONE (1) HELICAL BLADE, AND ONE (1) UNKNOWN 5.0MM SCREW WERE REMOVED. THE RIGHT LIMB INCURRED A SECONDARY FRACTURE OF THE PROXIMAL FEMUR UPON THE NAIL REMOVAL. THIS FRACTURE WILL BE ADDRESSED AT A LATER DATE. THERE WAS NO SURGICAL DELAY. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11.0MM TI HELICAL BLADE 100MM. THIS IS REPORT 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125013 11.0MM TI HELICAL BLADE 100MM ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 456.305 6191314 10886982226716

    Patients

    Seq Age Sex Outcome Treatment
    1