MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 3MM COMPRESSION SCREW SYSTEM - INTERFRAG

Model Number	SK18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2021, all hardware was removed in a revision surgery on (b)(6) 2022 due to irritation and pain.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 on (b)(6) 2021, all hardware was removed in a revision surgery on (b)(6) 2022 due to irritation and pain.It was confirmed that the patient's bones were completely fused.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.The device history records were reviewed and no non-conformances or issues during the manufacture or release of the products were identified that could have contributed to what was reported.Additional tmc devices explanted in the same revision surgery were reported in mdrs 3011623994-2021-00040 and 3011623994-2021-00041.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined.Based on the available information, 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.

• Brand Name: 3MM COMPRESSION SCREW SYSTEM - INTERFRAG
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer Contact: uriza shums ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 14403481
• Report Number: 3011623994-2022-00039
• Device Sequence Number: 5538102
• Product Code: HWC
• UDI-Device Identifier: 00853114006068
• UDI-Public: 00853114006068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 05/13/2022

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 Expiration Date: 11/13/2022
• Device Model Number: SK18
• Device Lot Number: 34452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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: 53 YR
• Patient Sex: Male