MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS HAMMERTOE IMPLANT-MEDIUM; SCREW

Model Number	SK32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial hammertoe surgery on (b)(6) 2024, the implant was removed on (b)(6) 2024 due to loss of correction in the second pip joint.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 after an initial hammertoe surgery on (b)(6)2024, the implant was removed on (b)(6) 2024 due to loss of correction in the second pip (proximal interphalangeal) joint.The joint was revised with a k-wire.Additional information indicates the patient stubbed his toe within several hours of returning home, dislocated his second mtp (metatarsophalangeal) joint as a result, but did not feel anything due to numbness.Follow-up from the surgeon indicates the patient is currently doing well.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.The device history records were reviewed and no issues were identified 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, additional information indicates it is likely that patient non-compliance contributed to what the patient experienced.The company will supplement this mdr as necessary and appropriate.

• Brand Name: HAMMERTOE IMPLANT-MEDIUM
• Common Device Name: SCREW
• 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: 20719255
• Report Number: 3011623994-2024-00204
• Device Sequence Number: 6555863
• Product Code: HWC
• UDI-Device Identifier: 00853114006259
• UDI-Public: (01)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 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): 11/18/2024

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: 300533514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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: Required Intervention
• Patient Sex: Male