BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 3061068 · Received April 16, 2013

    Report

    Report Number
    3003506883-2013-00175
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED.

    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 RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL AND HELICAL BLADE CONSTRUCT ON AN UNKNOWN DATE. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. IT IS NOT KNOWN IF THE PATIENT WAS COMPLAINING OF PAIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE NAIL AND THE HELICAL BLADE. PATIENT WAS REVISED WITH ANOTHER TROCHANTERIC FIXATION NAIL (10MM X 360MM RIGHT 125 DEGREE) AND HELICAL BLADE (11MM X 85MM). AUTOGRAFT WAS COLLECTED WITH THE RIA SYSTEM AND THE GRAFT WAS IMPLANTED INTO THE NONUNION SITE REPORTEDLY. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163706 11.0MM TI HELICAL BLADE 95MM HSB SYNTHES ELMIRA 6005360

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention