BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 115MM

    MDR report key: 4208733 · Received October 29, 2014

    Report

    Report Number
    3003506883-2014-10135
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE HISTORY RECORD SHOWS LOT# 6820155 OF 11.0MM TI HELICAL BLADE 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 (6664549) MET ALL SPECIFICATIONS EXCEPT THE BARS HAD PAINTED ENDS. THE BAR ENDS ARE CUT OFF AND DISCARDED, AND WOULD NOT HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL HARDWARE REMOVAL WAS PERFORMED. THE ORIGINALLY IMPLANTED HELICAL BLADE CUT OUT OF THE FEMORAL HEAD. THE PATIENT'S BONE HAD DISINTEGRATED. THERE WAS A REVISION TO A HEMIARTHROPLASTY. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693094 11.0MM TI HELICAL BLADE 115MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES ELMIRA 6820155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention