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 Infection (4544)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2020, two plates and eight screws were removed on (b)(6) 2021 due to a suspected infection.Upon hardware removal, no failure or deficiency was found with any tmc hardware and the patient's bones were fully fused/healed.Additional information indicates culture tests came back negative and the surgeon believes what the patient had were only visible signs of infection superficial to the incision site which were unrelated to the hardware.The device history records for kit sk14 were reviewed and no issues were identified during the manufacture, sterilization or release of the kit that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined.The surgeon ultimately determined what the patient experienced was a superficial infection of the skin only, which was likely acquired post-operatively based on the available information.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2020, two plates and eight screws were removed on (b)(6) 2021 due to a suspected infection.Upon hardware removal, no failure or deficiency was found with any tmc hardware and the patient's bones were fully fused/healed.

• Brand Name: LAPIPLASTY SYSTEM 2
• Type of Device: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer Contact: julia white ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 12682822
• MDR Text Key: 278574645
• Report Number: 3011623994-2021-00058
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: SK14
• Device Lot Number: 20030023769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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: 50 YR