BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 20328678 · Received September 27, 2024

    Report

    Report Number
    3007593722-2024-00012
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 1, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE BROKEN DYNANAIL OUTER BODY WAS CONFIRMED VIA X-RAY. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION AS TO THE CAUSE, BUT NO FURTHER INFORMATION WAS PROVIDED. THE PARTS WERE NOT RETURNED FOR ANALYSIS. NO INFORMATION WAS PROVIDED FOR THE ORIGINAL IMPLANT DATE SO DEFINITIVE CONCLUSIONS CANNOT BE MADE. MULTIPLE CAUSE FOR THE NAIL BREAKING EXIST INCLUDING MATERIAL FAILURE, EXCESSIVE FORCES PLACED ON THE NAIL, AND NON-UNION OF THE BONE. THESE CAN OCCUR FROM PRE-FUSION WEIGHT BEARING, LONG TERM NON-UNION, OR MANUFACTURING/MATERIAL DEFECTS. 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. THE REPORTED EXPLANT WAS NOT RETURN FOR INVESTIGATION SO A DEFINITIVE CAUSE COULD NOT BE DETERMINED. 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 THIS WAS A REMOVAL OF THE DYNANAIL. THE NAIL WAS BROKEN INTO TWO PIEVES - THE NITINOL REMAINED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962379 ACTIVE ADAPTIVE DYNANAIL HWC MEDSHAPE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention