BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 3222751 · Received July 12, 2013

    Report

    Report Number
    3003506883-2013-00298
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ONE NONCONFORMANCE NOTED. NONCONFORMANCE (B)(4) WAS WRITTEN AS A RESULT OF PAINT ON THE ENDS OF THE RAW MATERIAL BAR STOCK. THIS PAINT IS AN IDENTIFICATION METHOD USED BY THE RAW MATERIAL SUPPLIER TO IDENTIFY SPECIFIC LOTS. THE PAINTED ENDS ARE REMOVED DURING ROUTINE MANUFACTURING STEPS AND WILL NOT AFFECT THE FINISHED PRODUCT. THE DISPOSITION OF THIS NONCONFORMANCE WAS TO PROCEED WITH NORMAL PROCESSING AND INSPECTION. NO ADVERSE AFFECT ON PRODUCT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, DURING WHICH THE SURGEON EXCHANGED A HELICAL BLADE FROM A SHORT TROCHANTERIC FIXATION NAIL (TFN) SYSTEM THAT HAD PROTRUDED MEDIALLY AND SUPERIORLY. THE ORIGINAL BLADE WAS 105 MM AND WAS REPLACED WITH A 90 MM BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322527 11.0MM TI HELICAL BLADE 105MM HSB SYNTHES ELMIRA 6849651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention