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

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

The devices were not returned to the manufacturer for evaluation.Non-conformance reports for all sks and sd20s were reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.It was reported that after an initial bilateral bunion surgery, all hardware in one foot was removed in a revision surgery on (b)(6) 2022 due to non-union.The patient was revised with new 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.Although a number of factors could have contributed to non-union of the patient's bones, based on feedback from the reporter, the non-union is likely a result of patient non-compliance following the initial surgery.The device is intended for fusion and non-union 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 bilateral bunion surgery, all hardware in one foot was removed in a revision surgery on (b)(6) 2022 due to non-union.The patient was revised with new 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.

• 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: 14018466
• MDR Text Key: 288782812
• Report Number: 3011623994-2022-00023
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• 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