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

Model Number	SK57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2025 due to pain and irritation on the medial side of the foot.No deficiencies or malfunctions were alleged/found with any tmc device, and no other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2025 due to pain and irritation on the medial side of the foot.Additional information indicates that upon review of radiographic images, the surgeon noted a slight tilt of the plate and observed the distal oblique locking screw may have been slightly short of the lateral cortex leading to angular instability of the plate.He noted adequate bone healing at the osteotomy site and that the pain was likely a result of feeling the hardware.The hardware was removed and the bone void was backfilled with a bone filler.Visual signs of potential metallosis were also noted.No other patient outcomes were reported as a result of this event.Hardware was returned for evaluation and shows evidence of use/damage as a result of initial implantation and/or removal efforts.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.Although several factors can contribute to the reported event, the most likely cause is operator technique and/or improper device selection as the distal oblique locking screw did not penetrate or pass the lateral cortex, resulting in instability of the plate.No deficiencies or malfunctions have been alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.

• Brand Name: NANOPLASTY SYSTEM
• 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: 22193695
• Report Number: 3011623994-2025-00055
• Device Sequence Number: 18299818
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• UDI-Public: (01)00810111222464(17)300124(10)300625068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K240173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SK57
• Device Lot Number: 300625068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: 46 YR
• Patient Sex: Female