MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. TMC SPEEDMTP; STAPLE

Model Number	SK59
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent an adductoplasty at the 2nd and 3rd tarsometatarsal (tmt) joints, a lapiplasty at the 1st tmt, and metatarsophalangeal (mtp) joint fusion.After the initial surgery on (b)(6) 2025, hardware was removed from the mtp joint on (b)(6) 2026 due to wound dehiscence and an exposed plate at the mtp incision site.All other incision sites were healed and the mtp joint was fused.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that the patient underwent an adductoplasty at the 2nd and 3rd tarsometatarsal (tmt) joints, a lapiplasty at the 1st tmt, and metatarsophalangeal (mtp) joint fusion on (b)(6) 2025.After the initial surgery on (b)(6) 2025, hardware was removed from the mtp joint on (b)(6) 2026 due to wound dehiscence and an exposed plate at the mtp incision site.All other incision sites were healed and the mtp joint was fused.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.The bone holes were packed with demineralized bone matrix (dbm) and the wound was stitched closed.Additional information indicates that although the surgeon could not be certain, he believes it is possible that the patient's controlled ankle motion (cam) boot was rubbing on the incision, resulting in what was reported.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Based on the available information, the most likely cause of what was reported is the patient's cam boot rubbing on the incision site.There were no deficiencies or malfunctions alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same hardware removal surgery was reported in 3011623994-2026-00017.

• Brand Name: TMC SPEEDMTP
• 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: 24284246
• Report Number: 3011623994-2026-00016
• Device Sequence Number: 15918269
• Product Code: JDR
• UDI-Device Identifier: 00810111223492
• UDI-Public: (01)00810111223492(17)291125(10)300603348
• 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: 2026
• 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): 02/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SK59
• Device Lot Number: 300603348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: 75 YR
• Patient Sex: Male