MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LESSER TMT FIXATION PACK; PLATES

Model Number	SK28
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	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after a bunion surgery on (b)(6) 2022, all hardware was removed in a revision surgery on (b)(6) 2023 due to 3 broken screws.Upon hardware removal, it was confirmed that 2 out of the 3 intended bones were completely fused/healed with a non-union in only one.Additional information indicates the patient was non-compliant with postoperative protocol.The patient was revised with tmc hardware, along with the use of a bone graft dowel.There was no other report of any patient impact or injury as a result of this event.No devices were returned to the manufacturer for evaluation.Review of the device history records found no issues 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 patient's post-operative activity likely subjected excessive bending stresses to the screws leading to their breakage and also resulting in the non-union.The instructions for use identifies warnings related to postoperative care.The device is intended for fusion/stabilization and non-union is a known potential adverse event identified in the instructions for use provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in mdrs 3011623994-2023-00133 & 3011623994-2023-00135.
Event or Problem Description
It was reported that after a bunion surgery on (b)(6) 2022, all hardware was removed in a revision surgery on (b)(6) 2023 due to 3 broken screws.Upon hardware removal, it was confirmed that 2 out of the 3 intended bones were completely fused/healed with a non-union in only one.The patient was revised with tmc hardware, along with the use of a bone graft dowel.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: LESSER TMT FIXATION PACK
• Common Device Name: PLATES
• 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: jacklyn hayman ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 17090833
• Report Number: 3011623994-2023-00134
• Device Sequence Number: 12284048
• 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: 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): 06/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2024
• Device Model Number: SK28
• Device Lot Number: 300051249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: 60 YR
• Patient Sex: Male