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

Catalog Number	2200-29-0000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - dynanail tray that had some major issues in the case.The outer tube brace was way too tight and could not be put on by hand, the tibial screws also missed the nail leading to a significant delay in surgery.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Operation inspected the 2200-29-0000 dynanail deployment frame.No visual or functional issues were found.Operation loaded a nail on to the frame and it was held correctly.The frame properly targeted the posterior-anterior screw and all medial-lateral screws.Operation was able to install and remove the outer tube brace from the frame.Frame operates as design no issue found.The dynanail tray (dnt-tray 204) was shipped without the manual adjustment knob and wheel retention pin, these components were shipped in a second shipment.The manual adjustment knob and wheel retention pin are parts that are removable components.
Additional Manufacturer Narrative
This supplemental has been created to correct section h6.If additional reporting on this event is provided as a supplemental report to this document.

• 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: 21973466
• Report Number: 3007593722-2025-00009
• Device Sequence Number: 9252574
• Product Code: HSB
• UDI-Device Identifier: M97022002900000
• UDI-Public: M97022002900000
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 09/30/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/24/2025; 10/01/2025
• 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