BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 80MM

    MDR report key: 3232572 · Received July 18, 2013

    Report

    Report Number
    1719045-2013-01791
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE APPROXIMATELY FIVE YEARS AGO. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION: THE RESULTS OF THE MANUFACTURING EVALUATION SHOWS THAT THE PART WAS RECEIVED INTACT WITH MINIMAL DAMAGE. THE ANODIZE SURFACE HAS BEEN WORN OFF DUE TO USAGE. THE LOT NUMBER AND PART NUMBER ETCH IS INTACT AND LEGIBLE. A SMALL AMOUNT OF DAMAGE EXISTS AROUND THE HORSESHOE AREA MOST LIKELY DUE TO FIELD USAGE. ALL MEASUREMENTS ACCEPTABLE EXCEPT FOR THE M5X0.5 THREAD NO GO MEASUREMENT NOT BEING ABLE TO BE OBTAINED DUE TO THE NOTED DAMAGE. BECAUSE THERE IS THE ONE FEATURE, THE NO GO THREAD, THAT CANNOT BE OBTAINED, THIS COMPLAINT IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF COMPLETE PARAPLEGIA AT T4-T5 SINCE 1979, STATUS POST RIGHT INTRAMEDULLARY NAIL FIVE YEARS AGO, WAS RECENTLY ADMITTED FOR SURGERY. THE PATIENT HAD AN EXPOSED IM NAIL UNDER THE RIGHT TROCHANTERIC PRESSURE ULCER FOR THREE MONTHS. HE ALSO HAD ASSOCIATIVE UNSTAGEABLE ULCERS OVER THE SACRUM AND LEFT ISCHIUM. ON (B)(6) 2013 THE PATIENT WAS RETURNED TO THE O.R. FOR REMOVAL OF THE IM NAIL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333645 11.0MM TI HELICAL BLADE 80MM HSB SYNTHES MONUMENT 4359132

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention