MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. CONTROL 360 SYSTEM; PLATE

Model Number SK12

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation.The device history records for all devices intended to be implanted were reviewed (b)(4) and no issues were identified during the manufacture and release of the device that could have contributed to the problem reported.It was reported that all tmc hardware was removed in a revision surgery on (b)(6) 2018 due to non-union.Radiographic evidence was reviewed which indicated at least two screws and one plate were broken.A number of factors could have contributed to the removal of all hardware, however based on the available information the explanting surgeon stated it was non-union of the patient's bones which he suspects was potentially caused by increased forces on the foot which the patient's pes planus (flat feet/fallen arches) contributed to.The device is intended for fusion/stabilization and non-union is a known potential adverse event identified in the instructions for use provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.

Event Description

After an original bunion surgery on (b)(6) 2018, all hardware was removed in a revision surgery on (b)(6) 2018 due to non-union.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: CONTROL 360 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: jacklyn hayman ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 8201256
• MDR Text Key: 131584901
• Report Number: 3011623994-2018-00052
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: (01)00853114006006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Model Number: SK12
• Device Lot Number: 23879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: 53 YR