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

Model Number	SK57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated fields: d9: is this device available for evaluation? yes, date returned to manufacturer: 07-08-2025.G3: date received by manufacturer: 07-08-2025.G6: type of report: 30-day follow-up.H2: if follow-up, what type: additional information, device evalaution.H3: device evaluated by manufacturer- yes.H6: type of investigation- 10, investigation findings: 3243.H11: the device was returned for evaluation.Analysis of the returned device confirms the screw was broken.The head of the broken screw was still inserted into the plate.The distal portion of the screw was not returned and could not be inspected.The damage observed on the plate aligns with what is typically expected during the removal process.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.Based on the analysis, the screw appears to have fractured due to bending stresses.The company will supplement this mdr as necessary and appropriate.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed during a revision surgery on (b)(6) 2025 due to pain, loss of correction and a broken screw that was discovered via a radiographic image from a 3-week post-op follow-up.The surgeon removed the hardware and inserted wires to hold the correction in place.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.A number of factors could have contributed to what was reported and although the most likely cause cannot be determined based on the available information, the broken screw was likely subjected to excessive bending stresses which resulted in its breakage and contributed to the loss of correction.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed during a revision surgery on (b)(6) 2025 due to pain, loss of correction and a broken screw that was discovered via a radiographic image from a 3-week post-op follow-up.No other patient outcomes were reported as a result of this event.

• 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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 22406886
• Report Number: 3011623994-2025-00071
• Device Sequence Number: 8294422
• 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,Followup
• Report Date (Section B): 07/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK57
• Device Lot Number: 300625068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/05/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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 Sex: Male