MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY SYSTEM 4A ANATOMIC MULTIPLANAR IMPLANTS; PLATE

Model Number	SK39
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2024 due to painful hardware.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 after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2024 due to painful hardware.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.Although several factors can contribute to the reported event, the most likely cause cannot be determined due to the limited information provided, and no device being returned.However, additional information indicates the patient had thin skin which could have contributed to what the patient experienced.There were no reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY SYSTEM 4A ANATOMIC MULTIPLANAR IMPLANTS
• Common Device Name: PLATE
• 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: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 20527870
• Report Number: 3011623994-2024-00193
• Device Sequence Number: 9171181
• Product Code: HRS
• UDI-Device Identifier: 00853114006327
• UDI-Public: (01)00853114006327
• 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: 2023
• Device Explanted Year: 2024
• 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): 10/24/2024

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: SK39
• Device Lot Number: 300364983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2023
• 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: 48 YR
• Patient Sex: Female