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

Model Number SK30

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2022, two plates and eight screws were removed in a revision surgery on (b)(6) 2022 due to nonunion.The patient was non-compliant and revised with non-tmc hardware.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.No devices were not returned to the manufacturer for evaluation.The device history records 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 nonunion of the patient's bones, based on feedback from the reporter, the nonunion is likely a result of patient non-compliance following the initial surgery.The device is intended for fusion and nonunion is a known potential adverse event identified in the instructions for use provided with the sterile kit, along with warnings related to postoperative care.The company will supplement the mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2022, two plates and eight screws were removed in a revision surgery on (b)(6) 2022 due to non-union.The patient was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.

• Brand Name: LAPIPLASTY MINI INCISION SYSTEM
• 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: 15612731
• MDR Text Key: 301819697
• Report Number: 3011623994-2022-00091
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006211
• UDI-Public: 00853114006211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200961
• 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: 10/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: SK30
• Device Lot Number: 37114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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: 44 YR
• Patient Sex: Male