MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS HAMMERTOE PEEK FIXATION SYSTEM - MEDIUM

Model Number	SK32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two months after an initial hammertoe surgery on 03/15/2024, all hardware in the patient's toe was removed when it was amputated due to carcinoma.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.
Additional Manufacturer Narrative
It was reported that approximately two months after an initial hammertoe surgery on (b)(6)2024, the patient's toe was amputated.Although the amputated toe contained the previously implanted tmc device, the amputation was due to carcinoma unrelated to the implantation of any tmc device.Additional information indicates the original surgeon knew there was a potential carcinoma in the toe and took out tissue during the initial surgery.After the tissue was sent off for testing and confirmed to be a carcinoma, the patient's toe was amputated as a result of this finding.It was also reported that the patient developed a post-op acquired infection three days after the initial surgery which was resolved with antibiotics.A new surgeon has taken over the patient's case and believes the infection was due to the original surgeon's poor post-op care and the infection being treated in an untimely manner.No facts suggest a causal relationship associated with the use, implantation, or explantation of a tmc device, nor any other contributions to the event.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 the company has determined the subject event in this mdr does not meet the criteria for reportability, given the significance of amputation, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21 cfr part 803.The company will supplement this mdr as necessary and appropriate.

• Brand Name: HAMMERTOE PEEK FIXATION SYSTEM - MEDIUM
• Common Device Name: FIXATION
• 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: 19971338
• Report Number: 3011623994-2024-00142
• Device Sequence Number: 8810557
• Product Code: HWC
• UDI-Device Identifier: 00853114006259
• UDI-Public: 00853114006259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222564
• 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
• Report Date (Section B): 08/13/2024

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: SK32
• Device Lot Number: 300496325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male