BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNANAIL

    MDR report key: 19779787 · Received July 18, 2024

    Report

    Report Number
    3007593722-2024-00007
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    LXH
    UDI-DI
    M97022001000000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPPORTED THAT THE TTC REMOVAL TOOL WAS BROKEN OFF INTO THE IMPLANT, INSIDE THE PATIENT, DURING REMOVAL ATTEMPTS. THERE WAS ONE SIMILAR COMPLAINT IDENTIFIED FOR A BROKE DYNANAIL TTC REMOVAL TOOL WITH A ROOT CAUSE OF INCORRECT SURGICAL TECHNIQUE. THERE WERE NO ABNORMALITIES IN REGARDS TO DHR REVIEW FOR THE REMOVAL TOOL. THE DAMAGED REMOVAL TOOL WAS NOT RETURNED SO VISUAL AND DIMENSIONAL INSPECTION DID NOT OCCUR. SIMULATED USE TESTING DID NOT OCCUR. THE REPORTER STATED THE "TTC REMOVAL TOOL WAS BROKEN OFF INTO THE IMPLANT, INSIDE THE PATIENT" AND WAS UNABLE TO BE REMOVED. AS THE NAIL WAS IMPLANTED FOR APPROXIMATELY 16 MONTHS AND THE REPORTER STATED THE JOINTS WERE COMPLETELY HEALED, POTENTIAL BONEY INGROWTH INTO NAIL MAY HAVE OCCURRED, INCREASING THE FORCE REQUIRED TO REMOVE THE DYNANAIL. HOWEVER, THERE WERE NO X-RAYS PROVIDED OF THE CONSTRUCT TO CONFIRM AND NO EXCESSIVE GROWTH NOTED. DUE TO THE LIMITED INFORMATION PROVIDED AS WELL AS THE REMOVAL TOOL NOT BEING REMOVED, THE ROOT CAUSE SHALL REMAIN AS UNKNOWN.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - THE TTC REMOVAL TOOL WAS BROKEN OFF INTO THE IMPLANT, INSIDE THE PATIENT, DURING REMOVAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978608 DYNANAIL REMOVAL TOOL LXH MEDSHAPE, INC. UNKNOWN M97022001000000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Other