MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 3.5MM TRANSVERSE SCREWS

Model Number	SK19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023 all hardware was removed in a revision surgery on (b)(6) 2023.According to the surgeon, clinical setting factors during the initial bunion surgery resulted in an inability to achieve appropriate correction.The surgeon and anesthesiologist disagreed with regards to tourniquet time.The surgeon felt rushed and had to perform part of the surgery "wet" (while the tourniquet was down), which she believes prevented her from achieving an appropriate correction.However, the revision surgery was performed and an ideal correction was achieved.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.Based on the available information, the most likely cause of what was reported is operator technique.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.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in mdr 3011623994-2023-00256 and mdr 3011623994-2023-00257.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023 all hardware was removed in a revision surgery on (b)(6) 2023.According to the surgeon, clinical setting factors during the initial bunion surgery resulted in an inability to achieve appropriate correction.

• Brand Name: 3.5MM TRANSVERSE SCREWS
• 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: 17878503
• Report Number: 3011623994-2023-00258
• Device Sequence Number: 7695195
• Product Code: HWE
• 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 Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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 Expiration Date: 09/02/2025
• Device Model Number: SK19
• Device Lot Number: 40538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: 38 YR
• Patient Sex: Female