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

Device Problem Malposition of Device (2616)

Patient Problem Perforation (2001)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that after an initial bunion surgery, an extruded screw was removed in-office on an unknown date as it was protruding through the skin.There was no other report of patient impact or injury as a result of this event.

Manufacturer Narrative

It was reported that after an initial bunion surgery, an extruded screw was removed in-office as it was protruding through the skin.Per the surgeon, the screw was in the intercuneiform joint space indicating the dorsal plate was initially placed incorrectly and suspects the patient was non-compliant after his initial bunion surgery.There was no other report of patient impact or injury as a result of this event.No devices were 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 screws 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.Although a number of factors could have contributed to what was reported, based on feedback from the surgeon, the most likely cause is incorrect placement of the dorsal plate and patient non-compliance/post-op activity.The surgical technique and instructions for use include statements regarding plate placement and post-operative care.The company will supplement the mdr as necessary and appropriate.

• Type of Device: SCREW
• 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: 16359148
• MDR Text Key: 309367075
• Report Number: 3011623994-2023-00026
• Device Sequence Number: 1
• Product Code: HWC
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male