MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS; PLATE

Model Number	SK12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery, all hardware was removed on (b)(6)2023 due to screw breakage, non-union and bunion recurrence.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, all hardware was removed on (b)(6)2023 due to screw breakage, non-union, and bunion recurrence.No other patient outcomes were reported as a result of this event.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, per the surgeon, the initial placement of the device and the patient's age could have contributed to what the patient experienced.The company will supplement this mdr as necessary and appropriate.

• Brand Name: SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS
• Common Device Name: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18288992
• Report Number: 3011623994-2023-00318
• Device Sequence Number: 6189489
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: 00853114006006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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 Model Number: SK12
• Device Lot Number: 40547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female