MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 3.0MM COMPRESSION SCREW SYSTEM - INTERFRAG

Model Number	SK18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an initial bunion surgery, a broken screw was discovered post-surgery.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, a broken screw was discovered post-surgery.No other patient outcomes were reported as a result of this event.Additional information from the surgeon also indicates the first metatarsal was over-corrected.The device was not returned for evaluation as it currently remains implanted in the patient with no scheduled plans to revise.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 and screws 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.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, the device was likely subjected to excessive bending stresses which resulted in its breakage.The company will supplement the mdr as necessary and appropriate.

• Brand Name: 3.0MM COMPRESSION SCREW SYSTEM - INTERFRAG
• 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: 17977023
• Report Number: 3011623994-2023-00272
• Device Sequence Number: 19739983
• 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: K213036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• 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
• Patient Sex: Unknown