BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM

    MDR report key: 3070630 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10770
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. 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.

    Description of Event or Problem · 1

    THE CONSULTANT WAS NOT PRESENT FOR THIS PROCEDURE HOWEVER, HE WAS INFORMED BY THE SURGEON THAT AS THE SURGEON WAS INSERTING AN EX-TIBIAL IMPLANT, HE WAS UNABLE TO EXTRACT THE GUIDE ROD FROM NAIL AND COULD NOT EXTRACT THE NAIL. THE SURGEON WORKED TO EXTRACT THE NAIL FOR APPROX. 30 MINUTES. ULTIMATELY, HE WAS ABLE TO REMOVE THE NAIL AND GUIDE ROD AND THEN INSERTED A NEW NAIL AND NEW GUIDE ROD WITHOUT FURTHER INCIDENT AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. HOWEVER, THE SURGEON ESTIMATES THAT AN ADDITIONAL 1 HOUR WAS ADDED TO THE CASE. UPON EXAMINATION OF THE AFFECTED PART, BY THE SURGEON AND CONSULTANT IT WAS NOTED THAT THERE WAS A PIECE OF CORTICAL BONE IN THE CENTER OF THE NAIL CANNULATION THAT WAS PRESSING THE GUIDE ROD AGAINST THE WALL PREVENTING FORWARD OR BACKWARD MOVEMENT. THIS IS 1 OF 2 REPORTS FOR EVENT# 10206.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171694 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM JDS SYNTHES MONUMENT 04.034.352S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention