BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL

    MDR report key: 19767986 · Received July 17, 2024

    Report

    Report Number
    3007593722-2024-00006
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 17, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97012000110300
    PMA / PMN Number
    D155711
    Adverse Event
    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

    THE REASON FOR THIS REVISION SURGERY, THE DOCTOR CONDUCTED A TTC REVISION ON (B)(6) 2024. THE PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2023. DR (B)(6) STATED THE PATIENT'S JOINTS HAD COMPLETELY HEALED BUT HE FEARED THERE WAS NOW AN INFECTION DUE TO THE HEALTH STATUS OF THE PATIENT. DR HIROSE ATTEMPTED TO REMOVE THE DYNANAIL FROM THE PATIENT AND WAS UNABLE TO BACKLAP THE IMPLANT OUT AFTER REMOVING ALL SCREWS. MULTIPLE ATTEMPTS WERE MADE USING THE ENOVIS PROVIDED REMOVAL TOOLS AS WELL AS SEVERAL OTHER RESOURCES AT THE HOSPITAL WITH NO SUCCESS. THE INFECTION WAS DETERMINED TO NOT BE INTO THE BONE JUST BELOW THE SKIN. THE NAIL WAS LEFT IN THE PATIENT. THE TTC REMOVAL TOOL WAS BROKEN OFF INTO THE IMPLANT, INSIDE THE PATIENT, DURING REMOVAL ATTEMPTS. THERE WERE (B)(4) SIMILAR COMPLAINTS IDENTIFIED FOR DYNANAIL REMOVALS. HOWEVER, ONLY (B)(4) SIMILAR COMPLAINTS ARE RELEVANT TO THIS EVENT AS THE OTHERS WERE DUE TO NONUNION/PATIENT NONCOMPLIANCE. DHR REVIEW DID NOT OCCUR FOR THE DYNANAIL IMPLANT AS THE PART AND LOT NUMBERS REMAIN UNKNOWN. IT IS UNKNOWN IF THE SURGICAL TECHNIQUE WAS ADHERED TO DO TO LIMITED INFORMATION PROVIDED. THE DYNANAIL WAS UNABLE TO BE REMOVED AND REMAINS IMPLANTED. THUS, VISUAL INSPECTION AND DIMENSIONAL INSPECTION DID NOT OCCUR. SIMULATED USE TESTING DID NOT OCCUR. THE REPORTER STATED THE REVISION WAS REQUIRED DUE TO A POSSIBLE "INFECTION DUE TO THE HEALTH STATUS OF THE PATIENT". THE JOINT WAS REPORTED AS "COMPLETELY HEALED" AND THERE WAS NO REPORTED FAILURE WITH THE DYNANAIL ASSEMBLY. THE INFECTION WAS "DETERMINED TO NOT BE INTO THE BONE JUST BELOW THE SKIN", BUT THE LOCATION OF THE REPORTED INFECTION REMAINS UNKNOWN. AS THERE WAS NO REPORTED DEFICIENCY WITH THE DYNANAIL CONSTRUCT, AND THE INFECTION CANNOT BE DEFINITELY ATTRIBUTED TO DYNANAIL, THE ROOT CAUSE SHALL REMAIN UNKNOWN. A SECOND REPORT HAS BEEN FILED FOR THE INSTRUMENT REPORT NUMBER 3007593722-2024-00007.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148495 DYNANAIL DYNANAIL, 10 X 300MM HSB MEDSHAPE, INC. UNKNOWN M97012000110300

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Other| R