BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 3073120 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10817
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL COMMON DEVICE CODE: HWC. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PART REMAINS IMPLANTED AND IS UNAVAILABLE FOR RETURN. THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, SURGEON IMPLANTED THE NAIL INTO THE FEMUR. AS THE HELICAL BLADE WAS INSERTED THROUGH THE NAIL, IT STOPPED APPROXIMATELY 5CM INTO THE BONE. X-RAYS CONFIRMED THE LOCKING MECHANISM OF THE NAIL FOR THE HELICAL BLADE WAS IN THE ENGAGED POSITION. THE HELICAL BLADE WAS REMOVED AND THE LOCKING MECHANISM WAS DISENGAGED TO THE UNLOCKED POSITION. THE HELICAL BLADE WAS REINSERTED AND THE LOCKING MECHANISM ON THE NAIL WAS RE-ENGAGED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT. PROCEDURE WAS EXTENDED FOR APPROXIMATELY 30-45 MINUTES. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173396 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6890351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention