MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY SYSTEM 2 - ANATOMIC BIPLANAR IMPLANTS; PLATE

Model Number	SK14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2022, all hardware was removed on (b)(6) 2024 due to a non-healing dorsal wound.The hardware was returned for evaluation.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 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.However, additional information from the surgeon indicates it is possible that a lingering infection or sensitivity to the hardware may have contributed to what the patient experienced.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 3011623994-2024-00077, 3011623994-2024-00079, 3011623994-2024-00080.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2022, all hardware was removed on (b)(6) 2024 due to a non-healing dorsal wound.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 2 - ANATOMIC BIPLANAR 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: 19188754
• Report Number: 3011623994-2024-00078
• Device Sequence Number: 8294754
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: 00853114006051
• 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: 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): 04/25/2024

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 Expiration Date: 08/15/2025
• Device Model Number: SK14
• Device Lot Number: 300215429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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: 49 YR
• Patient Sex: Female