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	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, a speedplate was removed and replaced during a revision surgery on (b)(6) 2025 due to non-union.Additional information indicates a non-tmc screw was also removed during the revision surgery and the patient was revised with non-tmc hardware.It was also noted the patient had poor bone quality.No other patient outcomes were reported as a result of this event.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all nonconformances for possible kits utilized in surgery were reviewed and no non-conformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported.Although several factors can contribute to the reported event, the most likely cause cannot be determined due to the limited information provided, and no device being returned.However, additional information from the surgeon indicates a combination of soft bone, obesity and medication may have contributed 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.
Event or Problem Description
It was reported that after an initial bunion surgery, a speedplate was removed and replaced during a revision surgery on (b)(6) 2025 due to non-union.No deficiencies or malfunctions were alleged/found with any tmc device, 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: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 22021266
• Report Number: 3011623994-2025-00046
• Device Sequence Number: 21027465
• Product Code: JDR
• UDI-Device Identifier: 00810111221771
• UDI-Public: 00810111221771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232387
• 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): 05/14/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female