MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. PYTHON PLATE RIGHT

Model Number	SD12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were returned to the manufacturer for evaluation on 12/27/2018.All locking screws and the biplanar plate were intact, only exhibiting wear expected from normal use.However, the python plate broke about 2mm right after the center hole meets the neck of the device.The device history records for device 1508-4001 (sd12) was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to the problem reported.Based on the information provided, upon reviewing radiographic images from a postoperative follow-up, it was observed that the python plate was broken.As a result, all hardware was removed in a revision surgery on (b)(6) 2018 and the patient was revised with non-tmc hardware.Although a number of factors could have contributed to the breakage of the plate, the surgeon indicated the patient came to the follow-up visit ambulating without the cam boot which he believes contributed to the broken hardware.The patient's non-compliance likely subjected excessive bending stresses to the plate which lead to its breakage.The instructions for use identify warnings related to postoperative care.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
After an initial bunion surgery on (b)(6) 2018, one plate (sd12) was found broken upon review of radiographic images from the patient's postoperative follow-up.All hardware was removed in a revision surgery on (b)(6) 2018 as a result and 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.

• Brand Name: PYTHON PLATE RIGHT
• Common Device Name: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• MDR Report Key: 8233349
• Report Number: 3011623994-2019-00005
• Device Sequence Number: 11234521
• Product Code: HRS
• UDI-Device Identifier: 00853114006044
• UDI-Public: (01)00853114006044
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K153531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: SD12
• Device Lot Number: 22471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR