MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM; PLATE

Model Number	SK12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2022, the dorsal plate was removed in a revision surgery on (b)(6) 2023 due to pain.According to the surgeon, the dorsal plate was placed too laterally and there was some distal overhang, which was causing the patient's pain.It was confirmed that the patient's bones were fully fused / healed.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 device was returned for evaluation.The device was visually inspected and exhibited wear expected from normal use and damage likely incurred during insertion and / or removal of the plate and screws used with the plate.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 surgeon's assessment, the most likely cause of what was reported is plate placement.There were no issues with healing of the surgical site, nor were there any deficiencies or malfunctions alleged / found with any tmc device.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2022, the dorsal plate was removed from in a revision surgery on (b)(6) 2023 due to pain.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.

• Brand Name: LAPIPLASTY SYSTEM
• Common Device Name: PLATE
• 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: 17410045
• Report Number: 3011623994-2023-00188
• Device Sequence Number: 15326804
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: 00853114006006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/27/2023

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 Expiration Date: 05/24/2025
• Device Model Number: SK12
• Device Lot Number: 39914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 57 YR
• Patient Sex: Female