MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS; PLATE

Model Number	SK12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an initial bunion surgery, a broken medial plate was discovered during a post-surgery follow-up.Although there has been no injury reported and no information has been received indicating this malfunction has resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, a broken medial plate was discovered during a post-surgery follow-up.Additional information indicates the patient has a large body mass index (bmi) and tissue tension.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 what was reported, the most likely cause cannot be determined due to the device not being returned for evaluation.However, it is possible the patient's large bmi and tissue tension could have contributed to what the patient experienced.Although there has been no injury reported and no information has been received indicating this malfunction has resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.

• Brand Name: SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS
• Common Device Name: PLATE
• 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: 18271881
• Report Number: 3011623994-2023-00313
• Device Sequence Number: 3956226
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: 00853114006006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• 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): 12/05/2023

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: SK12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/05/2023
• 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: Female