BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 20488362 · Received October 18, 2024

    Report

    Report Number
    3007593722-2024-00016
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    September 25, 2024
    Report Date
    August 1, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97012000110220
    PMA / PMN Number
    D155711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION AS TO THE CAUSE FOR THE PARTS BEING EXPLANTED BUT NO FURTHER INFORMATION WAS PROVIDED. THE PARTS WERE NOT RETURNED FOR ANALYSIS. MULTIPLE CAUSE FOR EXPLANT COULD HAVE OCCURRED INCLUDING NON-FUSION, IMPLANT COMPONENT BREAKS, INFECTION, AND PAIN. THE DYNANAIL RISK ANALYSIS MATRIX DOCUMENTS DFMEA-FA001-0000, REV A, AND DFMEA-FA001-0001, REV A, WERE REVIEWED. MULTIPLE LINE ITEMS/CAUSES ARE ASSOCIATED WITH REMOVAL/EXPLANT OF THE DEVICE WITH VARYING DEGREES OF DETECTION, PATIENT/DEVICE SEVERITY, AND OCCURRENCE. COMPLAINT HISTORY WAS REVIEWED FROM (B)(6) 2024 (1ST COMPLAINT RECORDS IN AGILE) TO (B)(6) 2025, RESULTING IN 10 COMPLAINTS (INCLUDING THIS ONE) OF A DYNANAIL TTC EXPLANT: TWO (2) NON-COMPLIANCE, TWO (2) INFECTION, TWO (2) UNKNOWN, ONE (1) PAIN, ONE (1) NON-FUSION, ONE (1) NAIL BREAK, AND ONE (1) INSTRUMENTS RELATED. BASED ON A SALES VOLUME OF 1545 FROM (B)(6) 2024, TO (B)(6) 2025, AND MULTIPLE POTENTIAL CAUSES (INCLUDING NON-DEVICE RELATED), THE OCCURRENCE LEVEL OF REMOTE IS APPROPRIATE FOR VARIOUS FAILURE MODES. THE DYNANAIL RISK ANALYSIS MATRICES DFMEA-FA001-0000, REV A, AND DFMEA-FA001-0001, WERE GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP, QS-7.1 REV 08. OCCURRENCE LEVEL COMPARISON IS IN ALIGNMENT WITH THAT PROCEDURE. THE REPORTED EXPLANT WAS NOT RETURN FOR INVESTIGATION SO A DEFINITIVE CAUSE COULD NOT BE DETERMINED. MULTIPLE POTENTIAL CAUSES FOR EXPLANT 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 UNKNOWN REVISION REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960291 ACTIVE ADAPTIVE DYNANAIL, 10 X 220MM HSB MEDSHAPE, INC. UNKNOWN M97012000110220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention