MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL HYBRID; 4 X 36MM HEADLESS SCREW, DYNANAIL MINI

Catalog Number	2600-04-4336
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that dynanail mini explanted to convert to total ankle.This complaint was opened in response to a dynanail mini headless screw and a dynanail mini hybrid screw that needed to be removed in order to put in a total ankle replacement system.The hazard is an anticipated risk and is not an indication of a systematic issue necessitating a capa investigation.The implants were removed to make room for a total ankle replacement and no issues with the screws were identified.Thus, no further action is needed.
Event or Problem Description
It was reported that dynanail mini explanted to convert to total ankle.

• Brand Name: DYNANAIL HYBRID
• Common Device Name: 4 X 36MM HEADLESS SCREW, 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: 23858314
• Report Number: 3007593722-2025-00027
• Device Sequence Number: 12009289
• Product Code: HWC
• UDI-Device Identifier: M97026000443360
• UDI-Public: M97026000443360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/19/2025

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: 2600-04-4336
• Device Lot Number: 06101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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