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

Model Number	SK57
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, the surgical site was revised on (b)(6) 2026 due to pain and plantar flexion/translation of the capital fragment.Additional information indicates the 10mm screw may have backed out slightly.No other patient outcomes were reported as a result of this event.It was determined the capital fragment was plantar translated during the initial bunion surgery.No devices were returned for evaluation as the devices remain implanted.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 available information, the most likely cause is operator technique as it was determined that the capital fragment was plantar translated during the initial bunion surgery.Additionally, it is possible the screw was not fully seated/locked into the plate during initial implantation, which could have led to an eventual backing out of the screw.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, the surgical site was revised on (b)(6) 2026 due to pain and plantar flexion/translation of the capital fragment.It was also noted that the 10mm screw may have backed out slightly.No other patient outcomes were reported as a result of this event.

• 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 ; 9043735940
• MDR Report Key: 24277559
• Report Number: 3011623994-2026-00015
• Device Sequence Number: 15544969
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• UDI-Public: (01)00810111222464(17)301016(10)300724026
• 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: 2026
• 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): 02/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK57
• Device Lot Number: 300724026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• 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 Age: 45 YR
• Patient Sex: Female