BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM

    MDR report key: 3200992 · Received July 2, 2013

    Report

    Report Number
    3003506883-2013-00282
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. 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. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED ON (B)(6) 2013 FOR RIGHT FEMUR FRACTURE. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2013 FOR REMOVAL OF TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND LOCKING SCREW DUE TO NON-UNION. REPORTEDLY, THE PATIENT EXPERIENCED PAIN/IRRITATION/DISCOMFORT. PATIENT RIGHT HIP HARDWARE REMOVAL WAS THEN REVISED TO TOTAL HIP ARTHROPLASTY. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301681 11.0MM TI HELICAL BLADE 95MM HSB SYNTHES ELMIRA 6815411

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention