BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE

    MDR report key: 2994061 · Received February 27, 2013

    Report

    Report Number
    3003506883-2013-10019
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Manufacturer
    SYNTHES (USA) ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO SAMPLE WAS RETURNED FOR EVAL. THE LOT NUMBER IS UNK THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ADVANCED THE HELICAL BLADE, THE LOCKING MECHANISM OF THE TROCHANTERIC FIXATION NAIL AND HELICAL BLADE DID NOT WORK. THE SURGEON TOOK AN X-RAY AND CONFIRMED THAT THE LOCKING MECHANISM IS DOWN AND THE PARTS ARE NOT LOCKED TOGETHER. THE HELICAL BLADE WAS DAMAGED. THE SURGEON REMOVED THE IMPLANTS AND USED NEW NAIL AND HELICAL BLADE TO COMPLETE THE PROCEDURE. THE INCIDENT PROLONGED THE SURGERY BY APPROX 30 MINS. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PT WAS UNHARMED. THIS IS 2 OF 2 REPORTS THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84144 11.0MM TI HELICAL BLADE HSB SYNTHES (USA) ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention