BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX

    MDR report key: 3173591 · Received June 17, 2013

    Report

    Report Number
    3003506883-2013-00255
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; 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 65MM TI SPIRAL 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

    ON (B)(6) 2012, CANNULATED HIND FOOT ARTHRODESIS NAIL SURGERY WAS PERFORMED. ON AN UNKNOWN DATE, AN X-RAY REVEALED THAT THE SPIRAL BLADE HAD BACKED OUT. THEREFORE, ON (B)(6) 2013, THE PATIENT UNDERWENT REVISION SURGERY AND A LONGER SPIRAL BLADE WITH AN END CAP WAS IMPLANTED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273063 TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES ELMIRA 6892231

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention