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

Model Number	SK53
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed during a revision surgery on (b)(6) 2025 due to loss of correction and the medial implant being displaced.The patient was non-compliant, fell down, and injured her foot.Upon removal of the hardware, it was confirmed the medial cuneiform was fractured.Additionally, it was noted that the patient had rheumatoid arthritis and poor bone quality.The surgeon chose not to replace the implants at that time.An update from the surgeon indicates an external rail was later inserted and the patient continued to be non-compliant.No deficiencies or malfunctions were alleged/found with any tmc device, and 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.Based on the available information, the most likely cause of what was reported is patient non-compliance and poor bone quality.No deficiencies or malfunctions have been alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same removal surgery were reported in 3011623994-2025-00110.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed during a revision surgery on (b)(6) 2025 due to loss of correction and the medial implant being displaced.The patient was non-compliant, fell down, and injured her foot.Upon removal of the hardware, it was confirmed the medial cuneiform was fractured.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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 23304697
• Report Number: 3011623994-2025-00109
• Device Sequence Number: 9980431
• Product Code: JDR
• UDI-Device Identifier: 00810111222396
• UDI-Public: (01)00810111222396(17)290312(10)300531516
• 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: 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): 10/15/2025

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: SK53
• Device Lot Number: 300531516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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 Age: 55 YR
• Patient Sex: Female