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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that after an initial right foot bunion surgery on (b)(6) 2020, an unknown quantity and combination of hardware was removed in a revision surgery on (b)(6) 2022.Due to limited information, no deficiencies/failures with any tmc hardware or other patient outcomes have been able to be confirmed.

Manufacturer Narrative

It was reported that after an initial right foot bunion surgery on (b)(6) 2020, an unknown quantity and combination of hardware was removed in a revision surgery on (b)(6) 2022.No device was returned for evaluation.The device history records for all possible lots were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to the removal of the hardware, based on the limited information available, the most likely cause of what was reported cannot be determined.No deficiencies or malfunctions have been confirmed/found with any tmc device.The company will supplement this mdr as necessary and appropriate.

• Brand Name: UNKNOWN LAPIPLASTY SYSTEM
• Type of Device: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081 5159
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081 5159
• Manufacturer Contact: jacklyn hayman ; 203 fort wade road, suite 150; ponte vedra, FL 32081-5159 ; 9043735940
• MDR Report Key: 14164665
• MDR Text Key: 290078520
• Report Number: 3011623994-2022-00033
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• 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: 59 YR
• Patient Sex: Female