BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 3052015 · Received April 11, 2013

    Report

    Report Number
    2520274-2013-01919
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TFN NAIL AND HELICAL BLADE IN THE HIP ON (B)(6) 2012. REPORTEDLY SOON AFTER THE PATIENT HAD THE TFN HIP PROCEDURE, THE PATIENT COMPLAINED OF PAINFUL KNEE. THE PATIENT CONTINUED COMPLAINING OF PAIN IN THE KNEE AND THE SURGEON DECIDED TO RETURN THE PATIENT TO THE O.R. ON (B)(6) 2013 TO REMOVE THE TFN NAIL AND HELICAL BLADE. IT WAS REPORTED THE REMOVAL OF THE TFN NAIL AND HELICAL BLADE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENTS AND THE KNEE WAS NOT INVADED. REPORTEDLY ALL HARDWARE WAS INTACT. THE PATIENT WAS NOT REVISED WITH ANY ADDITIONAL HARDWARE AFTER THE REMOVAL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155269 11.0MM TI HELICAL BLADE 95MM HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention