MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 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 Code	Pain (1994)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, all hardware was removed on(b)(6) 2023 due to painful hardware.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 information indicates there was no loss of correction.Requests for additional information have been made with limited information received.The hardware was returned for evaluation.All devices show evidence of use, damage as a result of initial implantation, and/or damage as a result of removal efforts.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for possible kits utilized in surgery were reviewed and no non-conformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported.Although several factors can contribute to the reported event, the most likely cause cannot be determined due to the limited information provided.No deficiencies or malfunctions have been alleged/found with any tmc device.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery was reported in mdr 3011623994-2023-00227 and 3011623994-2023-00229.
Event or Problem Description
It was reported that after an initial bunion surgery, all hardware was removed on (b)(6) 2023 due to painful hardware.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.

• Brand Name: 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: renae ginter ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 17715665
• Report Number: 3011623994-2023-00228
• Device Sequence Number: 2189566
• 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): 09/08/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 37 YR
• Patient Sex: Female