MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS; PLATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that after an initial bunion surgery, all hardware was removed on 03-04-2024 due to non-union.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.

Manufacturer Narrative

It was reported that after an initial bunion surgery, all hardware was removed on 03-04-2024 due to non-union.According to the surgeon, the patient was non-compliant and did not follow post-op protocol.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.No devices were returned for evaluation.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.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, per feedback from the surgeon, it is likely that patient non-compliance contributed to what the patient experienced.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with the placement of the device.The company will supplement this mdr as necessary and appropriate.

Manufacturer Narrative

D9: device available for evaluation?: yes, returned to manufacturer: 03-19-2024.G3: date received by manufacturer: 03-19-2024.H3: device evaluated by manufacturer?: yes.H6: type of investigation: 10.Investigation findings: 213.H11: based on analysis, although the manner in which the screw broke cannot be determined, it likely was subjected to bending stresses at the time of its breakage.No fault was found with the other devices aside from expected wear from a combination of use and damage from implantation/explantation efforts.The company will supplement this mdr as necessary and appropriate.

• Type of Device: 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: 18990139
• MDR Text Key: 338784026
• Report Number: 3011623994-2024-00051
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female