BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 85MM

    MDR report key: 3435579 · Received October 29, 2013

    Report

    Report Number
    3003506883-2013-00391
    Event Type
    Injury
    Date Received
    October 29, 2013
    Report Date
    October 7, 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 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.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED THAT REVISION WAS REQUIRED TO REMOVE TFN NAIL FROM PATIENT'S RIGHT HIP DUE TO NON-UNION. A CONVERSION TO A TOTAL HIP REPLACEMENT WAS ALSO MADE ON THE DATE OF REVISION. REVISION WAS PERFORMED WITHOUT INCIDENT. THIS IS REPORT ONE OF THREE FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554644 11.0MM TI HELICAL BLADE 85MM HSB SYNTHES ELMIRA 7119525

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention