MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY MINI-INCISION SYSTEM; PLATE

Model Number	SK30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, the medial plate and four screws were removed in a revision surgery on (b)(6) 2023 due to nonunion and a broken medial plate.The site was revised with non-tmc hardware and no other patient outcomes were reported as a result of this event.According to the surgeon, the patient was non-compliant and the patient's bones were partially fused (75%) as only 25% was not fused.No devices were returned for evaluation.The device history records were reviewed, and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, based on feedback from the surgeon, the most likely cause of what was reported is patient non-compliance.The device was likely subjected to excessive bending stresses leading to its breakage.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, the medial plate and four screws were removed in a revision surgery on (b)(6) 2023 due to nonunion and a broken medial plate.The site was revised with non-tmc hardware and no other patient outcomes were reported as a result of this event.

• Brand Name: LAPIPLASTY MINI-INCISION 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: 17549563
• Report Number: 3011623994-2023-00202
• Device Sequence Number: 6676582
• Product Code: HRS
• UDI-Device Identifier: 00853114006211
• UDI-Public: 00853114006211
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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: SK30
• Device Lot Number: 41257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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: 51 YR
• Patient Sex: Female