MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS 18X14MM RAPID COMPRESSION IMPLANT; STAPLE

Model Number	SK51
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	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed and replaced during a revision surgery on (b)(6) 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.Although a number of factors could have contributed to what was reported, additional information indicates it is likely that the patient non-compliance could have contributed to what the patient experienced.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2024-00214, 3011623994-2024-00216, 3011623994-2024-00217.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed and replaced during a revision surgery on (b)(6) 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.

• Brand Name: 18X14MM RAPID COMPRESSION IMPLANT
• Common Device Name: STAPLE
• 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: 20701124
• Report Number: 3011623994-2024-00215
• Device Sequence Number: 15099020
• Product Code: JDR
• UDI-Device Identifier: 00810111221771
• UDI-Public: (01)00810111221771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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
• Report Date (Section B): 11/15/2024

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: SK51
• Device Lot Number: 300490086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male