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

Model Number SK1?

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery, all tmc hardware was removed in a revision surgery on (b)(6) 2020 due to irritation.The device was not returned to the manufacturer for evaluation.Device specific lot information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for sk12 and sk14 were reviewed and no non-conformances or issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.Based on the available information, the cause of what was reported 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 reported 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, all hardware was removed in a revision surgery on (b)(6) 2020 due to irritation.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.

• Brand Name: LAPIPLASTY SYSTEM
• 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: uriza shums ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 10975338
• MDR Text Key: 220460735
• Report Number: 3011623994-2020-00035
• Device Sequence Number: 1
• Product Code: HRS
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SK1?
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• 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