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 Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2025 due to swelling and potential post-op acquired infection.No deficiencies or malfunctions were 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, all hardware was removed on (b)(6) 2025 due to swelling and potential post-op acquired infection.Additional information indicates the patient's bones were completely fused/healed.The hardware was returned for evaluation.Upon receiving the devices, it was noted that the 18mm screw was still inserted into the plate and the tip of a driver used to insert or remove the screw had broken off into the screw head.Damage to the mating threads of the 10mm screw and the plate were also noted.Uneven wear on the lobe of the plate suggests the possibility of off-axis insertion.The source of the damage on either component could not be determined.Additional damage observed on the plate aligns with what is typically expected during the removal process.Measurements taken on the undamaged portion of the screw confirmed those features were within specification.No other issues were found with the returned devices.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.Based on the analysis and available information, the most likely cause cannot be determined.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: renae ginter ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 22522066
• Report Number: 3011623994-2025-00077
• Device Sequence Number: 12782059
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• UDI-Public: (01)00810111222464(17)291021(10)TM1126
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K240173
• 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): 07/16/2025

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: TM1126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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 Age: 71 YR
• Patient Sex: Male