MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; DYNANAIL MINI

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to loosening.
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
See h6 and h11.The complaint was opened for a report for a dynanail mini revision surgery that occurred to remove the implant due to the proximal interlock having backed out and a non-union of the medial column.The original surgery date is unknown, and the original physician of the surgery is also unknown.The sample was discarded at the facility so a complete evaluation and investigation could not be conducted.In a review of the dynanail mini risk matrix the potential failure mode of fixation screws backing out of bone is recorded and accounted for.The potential cause of the failure is documented as insufficient friction of screw threads to bone.Other potential causes of failure could be improper surgical technique or patient non-compliance.The hazard is ranked with a detection score of 1, severity of 3 and occurrence of 1.After a historical search from the time frame of 03/01/20204 to 03/01/2025, it was concluded that this was the first occurrence of this failure mode to this product family.This is an isolated case, and the first occurrence reported.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.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: 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: 21579853
• Report Number: 3007593722-2025-00002
• Device Sequence Number: 9456948
• Product Code: HSB
• UDI-Device Identifier: M97029000700000
• UDI-Public: M97029000700000
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 09/04/2025

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: Required Intervention
• Patient Sex: Unknown