MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. NANOPLASTY SYSTEM; PLATE

Model Number	SK57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, hardware was removed and replaced during a revision surgery on (b)(6) 2025 due to a displaced capital fragment after the patient tripped and fell.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, hardware was removed and replaced during a revision surgery on (b)(6) 2025 due to a displaced capital fragment after the patient tripped and fell.Less than two weeks after the initial surgery, the patient tripped and fell when their boot caught on carpet resulting in displacement of the capital fragment.The surgeon believed the patient was walking too much, too early.Two screws (10mm and 18mm) were removed during the revision surgery.The surgeon redrilled, corrected placement of the capital fragment and replaced the two screws.Additional information indicates the patient had a recent follow-up and is doing well.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event is the patient's post-operative activity.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with initial placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.

• Brand Name: NANOPLASTY SYSTEM
• Common Device Name: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9049131020
• MDR Report Key: 23855790
• Report Number: 3011623994-2025-00135
• Device Sequence Number: 21429870
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• UDI-Public: (01)00810111222464(17)300424(10)300647423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• 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 Model Number: SK57
• Device Lot Number: 300647423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: Required Intervention
• Patient Sex: Female