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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Swelling/ Edema (4577)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that after an initial bunion surgery, the dorsal plate was backing out on the metatarsal side.The patient is experiencing swelling, dorsal foot pain and has a nonunion.The device was not returned to the manufacturer for evaluation as all tmc hardware currently remains implanted.It was reported that after an initial bunion surgery, the dorsal plate was backing out on the metatarsal side.The patient is experiencing swelling, dorsal foot pain and has a nonunion.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined based on the available information.However, it is possible the screw(s) were not completely locked during initial placement and/or post-operative activity of the patient led to the plate backing out.The instructions for use and surgical technique include statements regarding post-operative care and the proper method for inserting screws into a plate.The company will supplement the mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery, the dorsal plate was backing out on the metatarsal side.The patient is experiencing swelling, dorsal foot pain and has a nonunion.All hardware currently remains implanted with no reported plans to revise.Although there has been no injury reported and this malfunction has not resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.

• 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: 17977355
• MDR Text Key: 326182333
• Report Number: 3011623994-2023-00273
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• 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