MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS 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	07/10/2025
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 on (b)(6) 2025 due to wound dehiscence.The patient received a ct scan to confirm the joint was fused.The wound was sutured closed once the hardware was removed.Additional information indicates removal of the hardware resolved the dehiscence and the patient is healing well.The surgeon believes the patient did not follow post-operative instructions and was walking in the boot with bare feet, which likely resulted in the boot rubbing directly onto the stitches, preventing proper healing of the wound.No deficiencies or malfunctions were alleged/found with any tmc device, and 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 record was 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 patient non-compliance as the surgeon believes post-operative instructions were not followed.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in mdrs 3011623994-2025-00079.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2025 due to wound dehiscence.The wound was sutured closed once the hardware was removed.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: TMC SPEEDMTP
• Common Device Name: STAPLE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 22611032
• Report Number: 3011623994-2025-00078
• Device Sequence Number: 20207152
• 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: K243658
• 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): 07/25/2024

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: 07/10/2025
• Initial Report FDA Received Date: 07/25/2025
• 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 Sex: Male