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

Model Number SK12

Device Problem Break (1069)

Patient Problems Skin Irritation (2076); Complaint, Ill-Defined (2331); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 04/17/2018

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.Based on the available information, all hardware was removed due to a broken plate.Since the device was not returned for evaluation, the most likely cause cannot be determined nor was it confirmed that the patient's tissue reaction was a result of the plate.However, it is likely the plates were subjected to excessive bending stresses which lead to their breakage.The instructions for use identify warnings related to postoperative care.The company will supplement the mdr as necessary and appropriate.

Event Description

After an original bunion surgery on (b)(6) 2017, all hardware was removed in a revision surgery on (b)(6) 2018 due to a broken plate.It was reported that the patient's tissue had an adverse reaction to the plate.The patient was revised with non-tmc hardware.There was no other report of any patient impact or injury as a result of this event.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer 05/22/2018.Manufacturer evaluated device.Additional information received from distributor 05/15/2018.Device evaluated by manufacturer? yes.Evaluation summary as follows: all locking screws and one (1) of the biplanar plates were intact, only exhibiting wear expected from normal use.However, the other (1) biplanar plate broke about 2mm right after the center hole meets the neck of the device.The bottom of the broken plate exhibited additional wear consistent with rubbing against bone which would be expected given that the patient's joint was not fused/healed.Based on the available information, the explanting surgeon confirmed non-union of the patients bones upon removal of the tmc hardware.The excessive bending stresses the plate was subjected to due to the non-union most likely lead to its breakage.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.The company will supplement the mdr as necessary and appropriate.Additional information received on 05/15/2018 indicated the "adverse tissue reaction" the patient experienced was just redness and inflammation, which a number of factors could have contributed to.

• 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
• MDR Report Key: 7509244
• MDR Text Key: 108093596
• Report Number: 3011623994-2018-00014
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: (01)00853114006006
• Combination Product (y/n): N
• PMA/PMN Number: K143717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/22/2020
• Device Model Number: SK12
• Device Lot Number: 22676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR