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

Model Number	SD11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.The device history records the device intended to be implanted (1508-4000) was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to the problem reported.The most likely cause cannot be determined due to the device not being returned.Although a number of factors could have contributed to the breakage of the plate, it is likely the plate was subjected to excessive bending stresses which lead to its breakage.The instructions for use identify warnings related to postoperative care.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
After an original bunion surgery on (b)(6) 2017, while reviewing radiographic images from a routine postoperative follow-up on (b)(6) 2017, the surgeon identified that the plate (sd-11) had broken.However, the surgeon indicated "observation only, no intervention" is required at this time as it is "likely unrecognized neuropathy".The device remains implanted with no revision scheduled at this time.

• Brand Name: PYTHON PLATE LEFT
• Common Device Name: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 3107 sawgrass village circle; ponte vedra beach FL 32082
• MDR Report Key: 6852314
• Report Number: 3011623994-2017-00037
• Device Sequence Number: 1419924
• Product Code: HRS
• UDI-Device Identifier: 00853114006037
• UDI-Public: (01)00853114006037
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K153531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/05/2019
• Device Model Number: SD11
• Device Catalogue Number: SD-11
• Device Lot Number: 21469
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1