MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; CONNECTION SCREW, M2.5, DYNANAIL MINI

Catalog Number	2900-24-0250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was opened for a report of a revision surgery to remove a dynanail mini connection screw after patient reported pain.Per the reporter, the dynanail mini was implanted approximately two years prior; the patient presented heel pain and after both an x-ray and mri revealed nothing conclusive to be causing pain, the physician chose to remove the implant to see if the pain would subside.The reporter stated that there was nothing wrong or any malfunctions from the device and screws.The sample was discarded at the facility.The dynanail mini risk matrix was reviewed and in it, the failure mode of any of the implantable components (screws, nail body and compressive or sliding element) not being biocompatible is recorded and accounted for where in the potential cause for the failure is that the biocompatibility is not confirmed.This is ranked with a detection score of 1, patient severity of 4, device severity of 1 and occurrence of 1.While the biocompatibility of the device causing the adverse patient reaction is a possible cause, it cannot be confirmed and the probable root cause for the pain leading to removal.Other potential causes could be abnormal patient anatomy, patient non-compliance, issues related to a separate surgery or other factors.Given the patient had no issues for two-years it is difficult to conclusively state the probable root cause, thus it remains unknown.A historical search was conducted from 13oct2024 to 13oct2025 and found that this was the first report of a dynanail mini revision surgery from an unknown cause occurrence.This is an isolated case, and the first occurrence reported.The probable root cause is unknown.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.
Event or Problem Description
Revision surgery - due to pain.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: CONNECTION SCREW, M2.5, DYNANAIL MINI
• 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: 23528612
• Report Number: 3007593722-2025-00018
• Device Sequence Number: 18397443
• Product Code: LXH
• UDI-Device Identifier: M97029002402500
• UDI-Public: M97029002402500
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: D151231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 11/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2900-24-0250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (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