BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 20328860 · Received September 28, 2024

    Report

    Report Number
    3007593722-2024-00013
    Event Type
    Injury
    Date Received
    September 28, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 1, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DYNANAIL TTC WAS EXPLANTED (B)(6) 2024 DUE TO THE NAIL BREAKING AND PAIN. THE DYNANAIL BREAK WAS CONFIRMED VIA X-RAY IMAGES FROM LINKEDIN POST. THE PARTS WERE NOT RETURNED FOR ANALYSIS. THE ORIGINAL IMPLANT DATE WAS APPROXIMATELY 1-YEAR PRIOR ON (B)(6) 2023. INFORMATION ON THIS CASE INDICATE THERE WAS SUBTALAR JOINT FUSION BUT NOT FULL TTC FUSION. THERE WAS A LATERAL PLATE WITH 3.5MM CORTICAL SCREWS IN THE TALUS AND TIBIA THAT LIKELY PREVENTED THE FULL TTC FUSION AND MAY HAVE CREATED A GREATER BENDING FORCE / STRESS POINT ON THE DYNANAIL CONTRIBUTING TO THE FATIGUE FAILURE AFTER OVER 1-YEAR POST OP. THE DYNANAIL RISK ANALYSIS MATRIX DOCUMENT DFMEA-FA001-0000, REV A, WAS REVIEWED. NAIL BODY BREAKS / BENDS HAS A WORST-CASE DETECTION LEVEL 2, PATIENT SEVERITY LEVEL 3, DEVICE SEVERITY LEVEL 3, AND OCCURRENCE LEVEL 1. COMPLAINT HISTORY WAS REVIEWED FROM (B)(6) 2024 (1ST COMPLAINT RECORDS IN AGILE) TO (B)(6) 2025, RESULTING IN 1 ADDITIONAL COMPLAINT (B)(4) OF A DYNANAIL TTC BREAKING. BASED ON A SALES VOLUME OF 1545 FROM (B)(6) 2024, TO (B)(6) 2025, THE OCCURRENCE LEVEL OF REMOTE IS APPROPRIATE. THE DYNANAIL RISK ANALYSIS MATRIX DFMEA-FA001-0000, REV A, WAS GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP, QS-7.1 REV 08. OCCURRENCE LEVEL COMPARISON IS IN ALIGNMENT WITH THAT PROCEDURE. BASED ON THE CASE INFORMATION, THE DYNANAIL BREAK WAS LIKELY A FATIGUE FAILURE DUE TO NON-UNION OF THE TTC JOINT AND/OR INCREASED BENDING FATIGUE DUE TO HARDWARE THAT REMAINED ACROSS THE TIBIA/TALUS POST OPERATIVELY. POTENTIAL CAUSES FOR THE NAIL BREAKING ARE APPROPRIATELY IDENTIFIED IN THE PRODUCT RISK ANALYSIS MATRIX. THE HISTORICAL COMPLAINT REVIEW DOES NOT INDICATE A SYSTEMIC PRODUCT ISSUE FOR ANY SPECIFIC CAUSE FOR EXPLANT.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO BROKEN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607687 ACTIVE ADAPTIVE DYNANAIL, 10 X 220MM HWC MEDSHAPE, INC. D0056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention