BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 3020840 · Received March 26, 2013

    Report

    Report Number
    3003506883-2013-10069
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, THE SURGEON WAS INSERTING THE HELICAL BLADE INTO THE NAIL AND THE END POSITION OF THE HELICAL BLADE WAS NOT CORRECT. THE FLAT PART OF THE FLUTE FOR THE HELICAL BLADE WAS NOT SUPERIOR AS IT SHOULD BE. THE SURGEON BACKED OUT THE HELICAL BLADE AND USED ANOTHER HELICAL BLADE. THE END POSITION OF THE HELICAL BLADE WAS STILL NOT CORRECT. THE FLAT PART OF THE FLUTE FOR THE HELICAL BLADE WAS NOT SUPERIOR. SURGEON LEFT THE HELICAL BLADE IN PLACE AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122955 11.0MM TI HELICAL BLADE 100MM HSB SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1