BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 2962956 · Received February 15, 2013

    Report

    Report Number
    3003506883-2013-00054
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH NAIL AND HELICAL BLADE AT THE PROXIMAL FEMUR ON (B)(6) 2012. AN X-RAY WAS TAKEN AFTER THE SURGERY SHOWED THE INJURED BONE WITH THE TFN HARDWARE. AN X-RAY WAS ALSO TAKEN SHOWING THE TFN CONSTRUCT ONE MONTH POST-OPERATIVE. REPORTEDLY THE SURGEON IS CONCERNED THAT THE BONE IS COLLAPSING LATERALLY INTO THE HEAD AND SHAFT OF THE FEMUR TOO MUCH. THE SURGEON DOES NOT PLANNING ON REPLACING THE HARDWARE AT THIS TIME. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68748 11.0MM TI HELICAL BLADE 105MM-STERILE HELICAL BLADE HSB SYNTHES ELMIRA 7027905

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR