MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC TMC 3.5MM COMPRESSION SCREW SYSTEM - TRANSVERSE

Model Number	SK19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2023 due to nonunion and pain.The site was revised with tmc hardware.Upon removal, there were no deficiencies or malfunctions 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, all hardware was removed in a revision surgery on (b)(6) 2023 due to nonunion and pain.The site was revised with tmc hardware.Upon removal, there were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.No devices were returned for evaluation.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformance for possible kits utilized in surgery were reviewed and no non-conformance or issues during the manufacture or release of the products were identified to date 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.There were no deficiencies or malfunctions alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in mdr 3011623994-2023-00112.

• Brand Name: TMC 3.5MM COMPRESSION SCREW SYSTEM - TRANSVERSE
• Common Device Name: SCREW
• 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: 16924948
• Report Number: 3011623994-2023-00113
• Device Sequence Number: 17894569
• Product Code: HWC
• UDI-Device Identifier: 00853114006075
• UDI-Public: 00853114006075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SK19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown