BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 110MM

    MDR report key: 2970999 · Received February 21, 2013

    Report

    Report Number
    3003506883-2013-00061
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL CONSTRUCT FOR A FEMUR FRACTURE ON AN UNSPECIFIED DATE. APPROXIMATELY 8 WEEKS STATUS POST-OPERATIVE, IT WAS REVEALED THROUGH RADIOGRAPHIC IMAGING THAT THE HELICAL BLADE ADVANCED THROUGH THE FEMORAL HEAD AND BREACHED THE ACETABULUM. IT WAS REPORTED THAT THE FEMUR FRACTURE WAS HEALED. SUBSEQUENTLY, ONLY THE HELICAL BLADE WAS EXPLANTED (B)(6) 2013. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76420 11.0MM TI HELICAL BLADE 110MM HELICAL BLADE HSB SYNTHES ELMIRA 6938324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention