MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2; PLATE

Model Number SK14

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

Patient Problem Pain (1994)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery ((b)(6) 2020), all hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing pain.Upon removal, the surgeon noted the hardware was slightly prominent, found no failure with any of the hardware, and indicated the intended bones were completely fused/healed.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site.The device was not returned to the manufacturer for evaluation, as it was discarded.The device history records for the device were reviewed and no issues were identified during its manufacture and release that could have contributed to what was reported.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery, all tmc hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing pain.Upon removal, the surgeon noted the hardware was slightly prominent, found no failure with any of the hardware, and indicated the intended bones were completely fused/healed.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site.

• Brand Name: LAPIPLASTY SYSTEM 2
• 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: 11103501
• MDR Text Key: 227922390
• Report Number: 3011623994-2020-00044
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: (01)00853114006051
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: SK14
• Device Lot Number: 19120013587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: 54 YR