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 Codes	Nonunion/Delayed-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2022, all hardware was removed in a revision surgery on (b)(6) 2023 due to nonunion and a broken screw.A portion of the broken screw was retained in the patient's bone as the surgeon was unable to remove it.The patient was revised with non-tmc hardware.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) 2022, all hardware was removed in a revision surgery on (b)(6) 2023 due to nonunion and a broken screw.A portion of the broken screw was retained in the patient's bone as the surgeon was unable to remove it.The patient was revised with non-tmc hardware.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 device was likely subjected to excessive bending stresses which resulted in the screw break and nonunion.The instructions for use identifies warnings related to postoperative care.The device is intended for fusion/stabilization and nonunion is a known potential adverse event identified in the instructions for use provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in mdrs 3011623994-2023-00150.

• 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: 17172204
• Report Number: 3011623994-2023-00149
• Device Sequence Number: 17900591
• 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: 2022
• 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): 06/21/2023

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 Expiration Date: 06/07/2025
• Device Model Number: SK30
• Device Lot Number: 40070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: 54 YR
• Patient Sex: Male