MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; FRAME ASSEMBLY, CF, DYNANAIL

Catalog Number	2200-29-0000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: FRAME ASSEMBLY, CF, DYNANAIL
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer (Section G): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer Contact: stacey bonnell ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4847879764
• MDR Report Key: 23612874
• Report Number: 3007593722-2025-00019
• Device Sequence Number: 10037650
• Product Code: HSB
• UDI-Device Identifier: M97022002900000
• UDI-Public: M97022002900000
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2200-29-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown