MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS NANOPLASTY 3D BUNION CORRECTION SYSTEM IMPLANT; PLATE

Model Number	SK57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, radiographic images indicate the patient's metatarsal fractured around the plate two weeks post-op.Additional information indicates that during the initial surgery, when trying to broach for implantation, the surgeon indicated the patient had very poor bone quality.Post-operatively, the surgeon stated the patient was aggressively weight-bearing without pain, which also may have contributed to the fracture.The device was not returned for evaluation as it currently remains implanted.Follow-up information received indicates the surgeon casted the patient to assist with healing of the fracture.The patient is doing well and happy with the bunion correction.The device history records were reviewed and found no deficiencies or malfunctions that could have contributed to this metatarsal fracture event.Unfortunately, the device itself cannot be evaluated as it remains implanted.Although a number of factors could have contributed to the fracture, it is probable that the patient's poor bone quality and heightened post-operative activity may have contributed to the event.No other patient outcomes were reported as a result of this event and all hardware currently remains implanted in the patient.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) 2024, radiographic images indicate the patient's metatarsal fractured around the plate two weeks post-op.No other patient outcomes were reported as a result of this event and all hardware currently remains implanted in the patient.
Additional Manufacturer Narrative
Updated fields: b5.Describe event: it was reported that during a routine follow-up, approximately two weeks after an initial bunion surgery on (b)(6) 2024, the patient's metatarsal fractured in the lateral aspect of the proximal shaft.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.H11.Corrected manufacturer narrative: it was reported that during a routine follow-up, approximately two weeks after an initial bunion surgery on (b)(6) 2024, the patient's metatarsal fractured in the lateral aspect of the proximal shaft.According to the surgeon, the patient had very poor bone quality (osteoporosis) with aggressive post-operative activity.The device history records were reviewed and found no deficiencies or malfunctions that could have contributed to this metatarsal fracture event.Unfortunately, the device itself cannot be evaluated as it remains implanted.Although a number of factors could have contributed to the fracture, the most likely cause cannot be determined with absolute certainty based on the available information.However, the surgeon believes the fracture was most likely a result of the patient's poor bone quality and heightened weight-bearing in the first two weeks post-surgery.Follow-up information received indicates the surgeon chose to leave the hardware in place and casted the patient to assist with healing of the fracture.The patient is doing well and happy with the bunion correction.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.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that during a routine follow-up, approximately two weeks after an initial bunion surgery on (b)(6) 2024, the patient's metatarsal fractured in the lateral aspect of the proximal shaft.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.

• Brand Name: NANOPLASTY 3D BUNION CORRECTION SYSTEM IMPLANT
• 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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 19675360
• Report Number: 3011623994-2024-00112
• Device Sequence Number: 15391306
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• UDI-Public: 00810111222464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K240173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SK57
• Device Lot Number: 300542404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female