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

Model Number	SK50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, a two-tine staple and four-tine staple were to be removed on (b)(6) 2026 due to dorsal soft tissue irritation.The two-tine staple was removed.However, the surgeon was unable to remove the four-tine staple in its entirety.Three of the four tines remain implanted.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 information indicates the patient's bones were completely fused/healed.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.The most likely cause of the reported event could not be determined based on the available information and without the return of the device.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in 3011623994-2026-00021.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, a two-tine staple and four-tine staple were to be removed on (b)(6) 2026 due to dorsal soft tissue irritation.The two-tine staple was removed.However, the surgeon was unable to remove the four-tine staple in its entirety.Three of the four tines remain implanted.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
This supplemental has been generated to include medwatch report mw5183130 as a related report (h10).

• 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: 24304062
• Report Number: 3011623994-2026-00020
• Device Sequence Number: 5214604
• Product Code: JDR
• UDI-Device Identifier: 00810111221788
• UDI-Public: (01)00810111221788(17)281016(10)300490085
• 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: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: SK50
• Device Lot Number: 300490085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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: 38 YR
• Patient Sex: Female