BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNANAIL HELIX

    MDR report key: 23824371 · Received December 16, 2025

    Report

    Report Number
    3007593722-2025-00022
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    UDI-DI
    M97032000170700
    PMA / PMN Number
    K203595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS GENERATED IN RESPONSE TO THE REPORT OF A DYNANAIL HELIX HEADLESS 70MM SCREW THAT BROKE INTRAOPERATIVELY. THE IMPLANT WAS BEING REMOVED IN A REVISION SURGERY, AND THE SCREW HEAD BROKE OFF THE IMPLANT. NO FRAGMENTS WERE LEFT IN THE PATIENT. THE ORIGINAL IMPLANT DATE WAS 9B)(6) 2023. THE REPORTER NOTED THE BONE QUALITY AS SCLEROTIC. THE BROKEN SAMPLE WAS DISCARDED AT THE FACILITY AND NOT RETURNED SO A COMPLETE EVALUATION AND INVESTIGATION COULD NOT BE COMPLETED. AN IMAGE WAS PROVIDED OF THE SAMPLE. ENGINEERING AND THE PRODUCT MANAGER VISUALLY INSPECTED THE IMAGE AND CONFIRMED ITS BREAKAGE. THE DYNANAIL HELIX RISK MATRIX WAS REVIEWED. IN IT, THE FAILURE MODE OF IMPLANT BREAKING INTRAOPERATIVELY IS DOCUMENTED AND ACCOUNTED FOR. THE POTENTIAL CAUSE OF FAILURE ARE LISTED AS MANUFACTURING ERROR (IMPLANT OUT OF SPECIFICATION), MISHANDLING OR MISUSE BY CLINICIAN, OR INADEQUATE DESIGN. THE HAZARD IS RANKED WITH A DETECTION OF 2, A PATIENT SEVERITY OF 2, A DEVICE SEVERITY OF 3 AND AN OCCURRENCE OF 1. THE DYNANAIL HELIX SURGICAL TECHNICAL GUIDE, WAS ALSO REVIEWED AND A POSSIBLE ROOT CAUSE OF THE IMPLANT BREAKING. THE PROPER TECHNIQUE FOR REMOVAL IS USING THE BLUE-HANDLE RATCHET DRIVER, IF OTHER TOOLS OR TECHNIQUES WERE USED IT COULD CAUSE THE DEVICE TO BREAK. IT IS UNKNOWN IF THE SURGICAL TECHNIQUE WAS ADHERED TO WITH THE INFORMATION PROVIDED, BUT THERE WERE NO REPORTED DEVIATIONS. A DEFINITIVE PROBABLE ROOT CAUSE REMAINS UNKNOWN. IN THE RISK MATRIX, THE FAILURE MODE IS RANKED WITH A DETECTION OF 3, SEVERITY OF 3 AND OCCURRENCE OF 1. A HISTORICAL SEARCH FROM THE TIME FRAME OF (B)(6) 2024 TO (B)(6) 2025, SHOWED THAT THIS WAS THE SECOND OCCURRENCE OF THIS PRODUCT FAMILY FAILURE MODE OF BREAKING POST-OPERATIVELY. THE DYNANAIL HELIX RISK ANALYSIS MATRIX REFERENCED ABOVE, WAS GENERATED USING THE LEGACY MEDSHAPE RISK MANAGEMENT SOP. SALES VOLUME AT THIS TIMEFRAME OF 2062 INDICATE THAT THIS HAZARD IS OCCURRING AT A .097% OCCURRENCE RATE, THIS IS ALIGNED WITH THE OCCURRENCE THRESHOLD SET BY THE PROCEDURES AND IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274340 DYNANAIL HELIX DYNAFUSE, HEADLESS 70MM, PACKAGED HWC MEDSHAPE, INC. UNKNOWN M97032000170700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention