BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 23612874 · Received November 20, 2025

    Report

    Report Number
    3007593722-2025-00019
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HSB
    UDI-DI
    M97022002900000
    PMA / PMN Number
    D155711
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS OPENED FOR TWO SEPARATE CASES OF THE SAME DYNANAIL FRAME USED FOR DYNANAIL TTC FUSIONS IN WHICH THE FRAME WOULD NOT ALIGN WITH THE NAIL ON THE TWO PROXIMAL SCREWS PROPERLY. THE REPORTER STATED THAT THE FRAME WAS ALIGNING ANTERIOR TO THE NAIL, SO EACH TIME THE SURGEON HAD TO USE LIVE X-RAY TO MOVE THE FRAME POSTERIOR TO ALIGN THE HOLES IN THE FRAME WITH THE HOLES IN THE NAIL. DURING THE FIRST CASE OF THE MISALIGNMENT WITH THE FRAME ON (B)(6) 2025, THE PATIENT TIBIA FRACTURED WHEN USING A 12X200 NAIL. TO GET ABOVE THE FRACTURE, THE SURGEON USED A 10X300 NAIL AND WAS ABLE TO FUSE THE ANKLE AND THIS CONCURRENTLY REDUCED THE TIBIA EFFECTS. THIS CASE EXPERIENCED A 30-MINUTE DELAY BUT WAS SUCCESSFUL WITH THE LONGER NAIL. THE REPORTER ON THE CASE STATED HE BELIEVED IT WAS CAUSED BY DRILLING AND PUTTING TORQUE ON THE TIBIA WHILE TRYING TO ALIGN THE FRAME AND NAIL. THERE WERE NO PATIENT COMPLICATIONS ON THE SECOND CASE OF THE FRAME MALALIGNMENT ON 10/23/25 AND THE SURGEON WAS ABLE TO COMPLETE THE CASE WHILE USING THE LIVE X-RAY. OPERATIONS AND ENGINEERING RECEIVED THE FRAME BACK AND CONDUCTED AN EVALUATION AND INVESTIGATION TO DETERMINE REFURBISHMENT ACTIVITIES. THE TEAM FOUND NO ISSUES WITH THE FRAME AND FOUND IT TARGETED AND ALIGNED CORRECTLY. SEE ATTACHED INSPECTION FORM FOR REFERENCE. THE FRAME WAS RETURNED TO SERVICE. THE DYNANAIL RISK ANALYSIS MATRIX RISK-FA001-0002: FMEA DYNANAIL TTC SYSTEM FMEA ANALYSIS (PFMEA, DFMEA, UFMEA) REV. A, WAS REVIEWED AND THIS FAILURE MODE IS CAPTURED AND RECORDED IN THE MATRIX AS DYNANAIL DOES NOT LINE UP WITH DEPLOYMENT FRAME. THE POTENTIAL CAUSES ARE CAPTURED AS DAMAGED NAIL OR FRAME, OR TOLERANCE STACK LEADS TO PARTS THAT DO NOT MATE. THE HAZARD IS RANKED WITH A SEVERITY OF 3 AND AN OCCURRENCE OF 4. A HISTORICAL SEARCH IN THE YEAR TIMEFRAME OF (B)(6) 2024 TO (B)(6) 2025 REVEALED THAT THERE WAS ONE OTHER COMPLAINT, (B)(4), RELATED TO AN ISSUE WITH MISTARGETING/MALALIGNMENT OF THE FRAME AND NAIL. HOWEVER, WITH THIS COMPLAINT, OPERATIONS FOUND NO ISSUE WITH ITS FUNCTION. BASED ON SALES VOLUME OF 1719 IN THE YEAR TIME FRAME, THE FAILURE MODE OCCURRENCE RATE STANDS AT (B)(4). THIS IS WITHIN THE ASSIGNED OCCURRENCE LEVEL PER THE PROCEDURE 3000.1635 FA - RISK MANAGEMENT. THE HAZARD IS AN ANTICIPATED RISK WITHIN THE RISK ANALYSIS MATRIX AND BEING WITHIN THE ASSIGNED OCCURRENCE THRESHOLD CONSTITUTED IT IS NOT AN INDICATION OF A SYSTEMATIC ISSUE NECESSITATING A CAPA INVESTIGATION. THEREFORE, NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    COMPLAINT - THE FRAME WAS NOT ALIGNED WITH THE NAIL ON THE TWO PROXIMAL SCREWS, SO THE DRILL KEPT HITTING THE NAIL. WE HAD TO PERFECT CIRCLE WITH X-RAY TO GET THE FRAME AND NAIL TO ALIGN.LEADING TO A SIGNIFICANT DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463995 ACTIVE ADAPTIVE FRAME ASSEMBLY, CF, DYNANAIL HSB MEDSHAPE, INC. UNKNOWN M97022002900000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other