MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 2.0MM SNAP-OFF SCREW SYSTEM

Model Number	SK21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2022, a screw was removed in a revision surgery on (b)(6) 2023 due to nonunion.The patient was revised with a new tmc screw.There was no other report of any patient impact or injury as a result of this event.Feedback from the surgeon indicates the screw was not positioned well during initial implantation, which she believes is the reason for the nonunion.A new screw was used to reposition the bone and re-fixate.No devices were returned for evaluation.The device history records were reviewed, and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, based on the available information, the revision is likely a result of the screw not being properly positioned during initial implantation.No deficiency or failure has been alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2022, a screw was removed in a revision surgery on (b)(6) 2023 due to nonunion.The patient was revised with a new tmc screw.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: 2.0MM SNAP-OFF SCREW SYSTEM
• 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: 17171937
• Report Number: 3011623994-2023-00148
• Device Sequence Number: 7153979
• Product Code: HWC
• UDI-Device Identifier: 00853114006143
• UDI-Public: 00853114006143
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/21/2023

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: 10/29/2022
• Device Model Number: SK21
• Device Lot Number: 28206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• 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: 31 YR
• Patient Sex: Female