BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT

    MDR report key: 3864247 · Received June 10, 2014

    Report

    Report Number
    1719045-2014-10256
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE PRODUCT WAS RECEIVED WITH DEBRIS BLOCKING THE CANNULATION INNER DIAMETER AT THE DISTAL END OF THE NAIL. THE REPORT INDICATES THAT THE DEVICE MATERIAL TIALB WITH NITON 06 WAS VERIFIED AND PASSED. COMPLAINT VISUALLY CONFIRMEDDEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BY TRYING TO GET THE 3.2 MM K-WIRE THROUGH THE NAIL IT WAS DETERMINED THAT THERE IS A "STONE" IN THE DISTAL END OF THE NAIL. IT WAS IMPOSSIBLE TO IMPLANT THE NAIL BY PUTTING IT OVER A K-WIRE IN THE MEDULLARY CANAL. IT WAS ALSO REPORTED THAT THE NAIL NEVER CAME INTO CONTACT WITH THE PATIENT. A 300MM NAIL WAS USED INSTEAD OF THE 340MM NAIL TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF FIVE MINUTES REPORTED. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337571 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7599204

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR