BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 85MM-STERILE

    MDR report key: 3312470 · Received August 27, 2013

    Report

    Report Number
    3003506883-2013-00344
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    August 1, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH ONE NONCONFORMANCE NOTED. NONCONFORMANCE NCR US1054813 WAS WRITTEN FOR A DOCUMENT ERROR. THE RAW MATERIAL CERTIFICATION WAS SUPPLIED WITH KSI UNITS USED FOR THE MECHANICAL TESTING AND THE REQUIREMENT IS FOR METRIC UNITS. THERE WAS NO ADVERSE AFFECT ON PRODUCT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HARDWARE REVISION OF A TROCHANTERIC NAIL. THE HELICAL BLADE HAD MIGRATED MEDIALLY INTO THE ACETABULUM. THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. THE MIGRATION WAS CONFIRMED VIA X-RAY AT THE END OF JULY. THE SHORT NAIL WAS REVISED TO A LONG NAIL AND THE HELICAL BLADE WAS REVISED TO A TROCHANTERIC FIXATION NAIL SCREW. THE HARDWARE WAS EASILY REMOVED AND NO ISSUES WERE NOTED DURING SURGERY. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420600 11.0MM TI HELICAL BLADE 85MM-STERILE HSB SYNTHES ELMIRA 7113865

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention