MAUDE Adverse Event Report: Treace Medical Concepts, Inc. Nanoplasty System; Screw

Model Number	SD29
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2026, a bi-cortical screw was removed on (b)(6) 2026 as it had backed out.Review of radiographic images indicated a post-operative fracture of the medial cortex.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) 2026, a bi-cortical screw was removed on (b)(6) 2026 as it had backed out.Review of radiographic images indicated a post-operative fracture of the medial cortex.The surgeon adjusted the post-op protocol to accommodate the fractured cortex.Additional information indicates immediate post-op images show that the screw was seated properly.The surgeon stated the patient was compliant but may have had a bone quality issue that was not anticipated.No other patient outcomes were reported as a result of this event.The patient has since been doing well.The screw was returned for evaluation and shows evidence of use/damage as a result of initial implantation and/or removal efforts.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 information provided, the most likely cause cannot be determined.However, it is possible that the patient's bone quality contributed to what the patient experienced.No deficiencies or malfunctions have been alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.

• Brand Name: Nanoplasty System
• Common Device Name: Screw
• 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 ; +1(904)373-5940
• MDR Report Key: 50819118
• Report Number: 3011623994-2026-00257
• Device Sequence Number: 10158256
• Product Code: HWC
• UDI-Device Identifier: 00810111222525
• UDI-Public: (01)00810111222525(17)300916(10)300690711
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: SD29
• Device Lot Number: 300690711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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 Sex: Female