MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SPEEDPLATE; STAPLE

Model Number	SK51
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, hardware was removed during a revision surgery on (b)(6) 2025 due to pain while running.Additional information indicates that the patient's bones were completely fused/healed.No deficiencies or malfunctions were alleged/found with any tmc device prior to removal and no other patient outcomes were reported as a result of this event.Hardware 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.Although several factors can contribute to the reported pain, the most likely cause cannot be determined.No deficiencies or malfunctions have been alleged/found with any tmc device prior to removal.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2025-00130 and 3011623994-2025-00131.
Event or Problem Description
It was reported that after an initial bunion surgery, hardware was removed during a revision surgery on (b)(6) 2025 due to pain while running.No deficiencies or malfunctions were alleged/found with any tmc device prior to removal and no other patient outcomes were reported as a result of this event.

• Brand Name: LAPIPLASTY SPEEDPLATE
• Common Device Name: STAPLE
• 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: 23824306
• Report Number: 3011623994-2025-00129
• Device Sequence Number: 20100527
• Product Code: JDR
• UDI-Device Identifier: 00810111221771
• UDI-Public: (01)00810111221771(17)290102(10)300510235
• 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 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): 12/16/2025

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: SK51
• Device Lot Number: 300510235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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