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

Model Number	SK60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware at the mtp joint was removed on (b)(6) 2025 due to dehiscence and a non-healing wound at the dorsal aspect of the hallux.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware at the mtp joint was removed on (b)(6) 2025 due to dehiscence and a non-healing wound at the dorsal aspect of the hallux.The wound was treated until the plate was exposed.Upon seeing the plate exposure, the surgeon chose to remove the hardware.The hardware was removed without issue.The patient's bones were fused/healed.The surgeon stated it is possible the patient's post-operative boot rubbed the incision and caused the wound.To assist in wound healing, an amniotic graft and wound vac were applied.The patient's post-operative care is now focused on wound care protocols.No other patient outcomes were reported as a result of this event.The hardware was not returned to the manufacturer 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.The most likely cause of the reported event is the patient's post-operative boot rubbing the incision and preventing proper healing of the wound.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 mdr 3011623994-2025-00119.

• 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: 23464619
• Report Number: 3011623994-2025-00120
• Device Sequence Number: 15682465
• Product Code: JDR
• UDI-Device Identifier: 00810111223515
• UDI-Public: (01)00810111223515(17)300204(10)300629591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242671
• 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): 11/04/2025

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: SK60
• Device Lot Number: 300629591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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: 66 YR
• Patient Sex: Female