MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 3.0MM INTERFRAG SCREW

Model Number	SK18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.A back-up device was available to successfully complete the case.No other patient outcomes were reported as a result of this event.Although this malfunction has not resulted in a revision surgery to date in this event, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, a mdr will be filed to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that a screw broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.A back-up device was available to successfully complete the case.No other patient outcomes were reported as a result of this event.The device was not 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, the most likely cause cannot be determined due to the device not being returned for evaluation.However, it is possible the device was subjected to excessive bending stresses leading to the breakage.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 3.0MM INTERFRAG SCREW
• 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 ; 9043735940
• MDR Report Key: 18062598
• Report Number: 3011623994-2023-00283
• Device Sequence Number: 12637362
• 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
• Device Implanted 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): 11/02/2023

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 Expiration Date: 07/11/2025
• Device Model Number: SK18
• Device Lot Number: 300125073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Female