BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL, 10 X 220MM

    MDR report key: 19235504 · Received May 2, 2024

    Report

    Report Number
    3007593722-2024-00005
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97012000110220
    PMA / PMN Number
    D155711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4/9 DR REMOVED THE ABOVE NAIL DUE TO THE PATIENT HAVE SEVERE PAIN IN HIS TIBIA ABOVE THE NAIL. THERE WAS NO STRESS FRACTURE OR ANY DEFECT IN THE BONE VISIBLE VIA XRAY SO DR FLINT DID NOT KNOW WHAT WAS CAUSING THE PAIN. DR WAS NOT CONCERNED WITH THE EFFECTIVENESS OF OUR NAIL AS THE TTC JOINTS HAD HEALED PERFECTLY. THIS NAIL WAS PUT IN APPROXIMATELY 12 MONTHS AGO. DR DECIDED TO SPAN THE ENTIRE TIBIA WITH A SUPRA PATELLAR TIBIAL NAIL FROM STRYKER AFTER REMOVING OURS. IMPLANTS WERE NOT ABLE TO BE OBTAINED AS HOSPITAL POLICY IS TO DISCARD. A SUPPLEMENTAL MDR REPORT WILL BE FILED FOR COMPLAINT (B)(4) WHEN ALL NECESSARY INFORMATION HAS BEEN OBTAINED AND THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    SEE A2 AND H11 IN CONCLUSION, NO ROOT CAUSE COULD BE DETERMINED AS TO WHY THE PATIENT HAD REPORTED PAIN ABOVE THE TIBIA DESPITE THE 10X220MM DYNANAIL DEVICE FULLY FUSING THE TTC JOINT AND NOT HAVING ANY BREAKAGE OR VISUAL DEFECTS. DEVICE HISTORY RECORD REVIEW SHOWS THAT THE ASSOCIATED FINISHED GOOD AND RAW MATERIALS USED WERE 100% CONFORMING TO SPECIFICATION AND DUE TO LACK OF THE ORIGINALLY IMPLANTED NAIL (DISCARDED BY FACILITY) FURTHER TESTING / EVALUATION CANNOT BE PERFORMED. SURGEON FEEDBACK AND OPERATIVE NOTES DO NOT SUGGEST THAT THE PAIN WAS RELATED TO PATIENT NON-COMPLIANCE TO PROTOCOLS, INJURY, OR ILLNESS, FURTHER EVIDENCED BY THE SUCCESSFUL TTC JOINT FUSION. DESPITE THIS PATIENT PAIN AND DYNANAIL REMOVAL, A NEW NAIL DEVICE AND SCREWS WERE IMPLANTED SUCCESSFULLY FROM A DIFFERENT COMPANY. WHILE NO ROOT CAUSE COULD BE IDENTIFIED, COMPLAINT HISTORY REVIEW DOES NOT SUGGEST A RECURRENCE FOR THIS FAILURE MODE. FOR THE ABOVE REASONS, NO FURTHER ACTIONS OR CAPA ARE NECESSARY IN RESPONSE TO THIS COMPLAINT. FUTURE SIMILAR REPORTS SHALL BE MONITORED AND ASSESSED PER 7000.010 GLOBAL COMPLAINT HANDLING PROCESS.

    Description of Event or Problem · 0

    ON 4/9 DR REMOVED THE ABOVE NAIL DUE TO THE PATIENT HAVE SEVERE PAIN IN HIS TIBIA ABOVE THE NAIL. THERE WAS NO STRESS FRACTURE OR ANY DEFECT IN THE BONE VISIBLE VIA XRAY SO DR FLINT DID NOT KNOW WHAT WAS CAUSING THE PAIN. DR WAS NOT CONCERNED WITH THE EFFECTIVENESS OF OUR NAIL AS THE TTC JOINTS HAD HEALED PERFECTLY. THIS NAIL WAS PUT IN APPROXIMATELY 12 MONTHS AGO. DR DECIDED TO SPAN THE ENTIRE TIBIA WITH A SUPRA PATELLAR TIBIAL NAIL FROM STRYKER AFTER REMOVING OURS. IMPLANTS WERE NOT ABLE TO BE OBTAINED AS HOSPITAL POLICY IS TO DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306063 DYNANAIL, 10 X 220MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB MEDSHAPE, INC. D0086 M97012000110220

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| O