MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2; PLATE

Model Number SK14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery, hardware was removed in a revision surgery on (b)(6) 2022 due to irritation.Additional information indicates the patient's bones were fully fused/healed.Upon removal, 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.No devices were not returned to the manufacturer for evaluation.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for possible kits utilized in surgery were reviewed and no nonconformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery, hardware was removed in a revision surgery on (b)(6) 2022 due to irritation.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
• Type of Device: 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: 16261644
• MDR Text Key: 308346545
• Report Number: 3011623994-2023-00021
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: 00853114006051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SK14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female