MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY LESSER TMT FIXATION PACK; PLATE

Model Number	SK28
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, one broken plate and two plates that may potentially be migrating were discovered during a post-surgery follow-up on (b)(6) 2024.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.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.Additional tmc hardware explanted in the same revision surgery was reported in mfr report # 3011623994-2024--00056 and 3011623994-2024--00062.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) 2023, one broken plate and two plates that may potentially be migrating were discovered during a post-surgery follow-up on (b)(6) 2024.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: LAPIPLASTY LESSER TMT FIXATION PACK
• Common Device Name: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 19004523
• Report Number: 3011623994-2024-00061
• Device Sequence Number: 9438619
• Product Code: HRS
• UDI-Device Identifier: 00853114006204
• UDI-Public: 00853114006204
• 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
• 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): 03/29/2024

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: SK28
• Device Lot Number: 300437105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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