BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL TTC FUSION NAIL

    MDR report key: 16639350 · Received March 29, 2023

    Report

    Report Number
    3007593722-2023-00001
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 3, 2023
    Report Date
    May 10, 2023
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDS
    PMA / PMN Number
    K113828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE BY THE COMPLAINT REPORTER, INCLUDING MULTIPLE EMAILS AND CALLS TO ASSOCIATES AT THE FACILITY. THE NEEDED INFORMATION FOR (B)(4) COULD NOT BE OBTAINED DURING ANY OF THESE ATTEMPTS MADE BY THE REPORTER OR TO THE FACILITY. ADDITIONALLY, THE COMPLAINT UNIT (BROKEN DYNANAIL) WAS NEVER RETURNED FOR INVESTIGATION. PER FDA 21 CFR 820.198 AND INTERNAL SOP, MULTIPLE "GOOD FAITH EFFORT" ATTEMPTS WERE MADE TO OBTAIN NECESSARY INFORMATION FOR COMPLAINT INVESTIGATION AND THE NEEDED INFORMATION COULD NOT BE OBTAINED. THIS COMPLAINT INVESTIGATION WILL BE CLOSED AS NO CONCLUSION CAN BE MADE AT THIS TIME AS TO A POTENTIAL CAUSE OF THE DYNANAIL BREAKAGE. THERE IS NO ABILITY TO DETERMINE IF THE BREAKAGE WAS THE RESULT OF A MEDSHAPE DEVICE DEFICIENCY. IF ANY FUTURE INFORMATION IS RECEIVED FOR THIS COMPLAINT, THE COMPLAINT INVESTIGATION AND MDR REPORT WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 CLINICAL SPECIALIST (B)(6) NOTIFIED ENOVIS FOOT AND ANKLE THAT A DYNANAIL TTC NAIL WAS REMOVED FROM A PATIENT IN WINTER GARDEN, FL AS THE NAIL AND INTERNAL COMPRESSIVE ELEMENT WERE BROKEN COMPLETELY THROUGH. MULTIPLE REQUESTS HAVE BEEN MADE TO OBTAIN INFORMATION, HOWEVER ALL REMAINING PATIENT, CASE AND DYNANAIL INFORMATION IS UNKNOWN AT THIS TIME. ON (B)(6) 2023 COMPLAINT INVESTIGATION (B)(4) WAS INITIATED TO INVESTIGATE THE NAIL BREAKAGE EVENT FOR ROOT CAUSE AND CORRECTIVE / PREVENTIVE ACTION, AS NECESSARY. AS PATIENT, OPERATIVE AND SURGEON INFORMATION REMAINS UNKNOWN AT THIS TIME, PER QSF-8.2.1.7, THIS COMPLAINT IS BEING FILED AS AN MDR AS IT IS POSSIBLE THAT A DEVICE MALFUNCTION RESULTED IN THE NAIL BREAKAGE. A SUPPLEMENTAL MDR REPORT WILL BE FILED FOR COMPLAINT (B)(6) WHEN ALL NECESSARY INFORMATION HAS BEEN OBTAINED AND THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 CLINICAL SPECIALIST (B)(6) NOTIFIED ENOVIS FOOT AND ANKLE THAT A DYNANAIL TTC NAIL WAS REMOVED FROM A PATIENT IN WINTER GARDEN, FL AS THE NAIL AND INTERNAL COMPRESSIVE ELEMENT WERE BROKEN COMPLETELY THROUGH. MULTIPLE REQUESTS HAVE BEEN MADE TO OBTAIN INFORMATION, HOWEVER ALL REMAINING PATIENT, CASE AND DYNANAIL INFORMATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385812 DYNANAIL TTC FUSION NAIL NAIL, FIXATION, BONE JDS MEDSHAPE, INC. 1200-01-1022 EXACT LOT NUMBER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other