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

Model Number	SK19
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, a transverse screw was removed on (b)(6) 2023 due to the screw backing out.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-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 a number of factors could have contributed to the screw backing out, the most likely cause cannot be determined based on the available information.However, it is possible the initial placement and/or post-operative activity of the patient led to the screw backing out.The instructions for use and surgical technique include statements regarding post-operative care and the proper device placement.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery, a transverse screw was removed on (b)(6) 2023 due to the screw backing out.No other patient outcomes were reported as a result of this event.

• 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: renae ginter ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 17927683
• Report Number: 3011623994-2023-00265
• Device Sequence Number: 17760479
• 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): 10/12/2023

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?: Yes
• 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: Not provided
• Initial Report FDA Received Date: 10/12/2023
• 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 Age: 38 YR
• Patient Sex: Male