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 Pain (1994)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2021, hardware (plates, screws, and a transverse screw) was removed in a revision surgery on (b)(6) 2022 due to irritation.Additional information indicates the patient's bones were fully fused.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.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.Additional tmc device explanted in the same revision surgery was reported in mdr 3011623994-2022-00098.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 on (b)(6) 2021, hardware (plates, screws, and a transverse screw) was removed in a revision surgery on (b)(6) 2022 due to irritation.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.

• 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: 15656074
• MDR Text Key: 302250760
• Report Number: 3011623994-2022-00097
• 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: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SK14
• Device Lot Number: 300023827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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 Age: 60 YR
• Patient Sex: Female