MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY 4.0MM FULLY THREADED SCREWS - LONG

Model Number	SK38
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, a fully threaded screw was removed on (b)(6) 2024 due to backing out and tenting the skin.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 bunion surgery on (b)(6) 2024, a fully threaded screw was removed on (b)(6) 2024 due to backing out and tenting the skin.No other patient outcomes were reported as a result of this event.Additional information indicates the patient's bones were completely fused/healed.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.A number of factors could have contributed to what was reported and although the most likely cause cannot be determined based on the available information, it is possible the screw that backed out was not completely locked into the plate during initial placement and/or post-operative activity of the patient led to loosening of the hardware.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY 4.0MM FULLY THREADED SCREWS - LONG
• 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: 20779855
• Report Number: 3011623994-2024-00205
• Device Sequence Number: 5051732
• Product Code: HWC
• UDI-Device Identifier: 00853114006303
• UDI-Public: (01)00853114006303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2025
• Device Model Number: SK38
• Device Lot Number: 300230565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• 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: Female