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 Problems Wound Dehiscence (1154); Fall (1848); Swelling/ Edema (4577)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2020, all hardware was requested to be removed due to what the patient believed was an allergic reaction to metal.There was no confirmation of a metal allergy, but the surgeon did mention the patient was possibly non-compliant and also reported the surgical site reopened when the patient fell in the parking lot at a follow-up visit.As a result of the incision site appearing infected and dehisced (open), all hardware was removed on (b)(6) 2020 to take cultures of the site and revise it with non-tmc hardware.The device was not returned to the manufacturer for evaluation.The device history record was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.No deficiencies or malfunctions have been alleged/found with any tmc device and the cultures confirmed there was no infection.The surgeon confirmed the patient is currently "doing better" with no residual issues.Based on the available information, it is likely that the patient's fall and/or potential non-compliance contributed to what was reported.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported after an initial bunion surgery on (b)(6) 2020, all hardware was requested to be removed due to what the patient believed was an allergic reaction to metal.There was no confirmation of a metal allergy, but additional information indicates the surgical site reopened when the patient fell in the parking lot at a follow-up visit.As a result of the incision site appearing "infected and dehisced", all hardware was removed on (b)(6) 2020 to take cultures of the site and revise it with non-tmc hardware.No deficiencies or malfunctions were alleged/found with any tmc device, nor were there any other outcomes as a result of this event.

• 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: 10782713
• MDR Text Key: 214473640
• Report Number: 3011623994-2020-00030
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2020

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
• Device Expiration Date: 06/29/2023
• Device Model Number: SK14
• Device Lot Number: 20060014029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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: 40 YR