MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 1; PLATE

Model Number	SK12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery in (b)(6) 2024, all hardware was removed and replaced during a revision surgery on (b)(6) 2025 due to discomfort, nonunion, and a broken dorsal lateral plate.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.A number of factors could have contributed to what was reported, and although the most likely cause cannot be determined based on the available information and without return of the device, the broken plate was likely subjected to excessive bending stresses which resulted in its breakage and contributed to the nonunion.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery in (b)(6) 2024, all hardware was removed and replaced during a revision surgery on (b)(6) 2025 due to discomfort, nonunion, and a broken dorsal lateral plate.No other patient outcomes were reported as a result of this event.

• Brand Name: LAPIPLASTY SYSTEM 1
• 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 ; 9043735940
• MDR Report Key: 22007593
• Report Number: 3011623994-2025-00045
• Device Sequence Number: 20806647
• Product Code: HRS
• UDI-Device Identifier: 00810111221337
• UDI-Public: (01)00810111221337(17)291004(10)43706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK12
• Device Lot Number: 43706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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 Sex: Female