MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC FASTPITCH 2.7MM HIGH PITCH LOCKING SCREW

Model Number	SD21
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, an unsuccessful attempt to remove a distal middle screw that was backing out of the plate was performed on (b)(6) 2024.The patient was also experiencing discomfort.No other patient outcomes were reported as a result of this event.Although the backed-out screw was unable to be removed & left implanted, there have been similar events where this malfunction has resulted in removal of the device.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, a distal middle screw that was backing out of the plate was discovered via radiographic image.An unsuccessful attempt to remove the screw was performed on (b)(6) 2024.The patient was also experiencing discomfort.No other patient outcomes were reported as a result of this event.Additional information indicates the surgeon was unable to remove the backed-out screw due to it being stripped.The screw was advanced into the plate again and left in place.It is unknown when the screw was stripped.No devices were returned for evaluation as the hardware remains implanted.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: FASTPITCH 2.7MM HIGH PITCH LOCKING SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC; 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: 21120614
• Report Number: 3011623994-2025-00002
• Device Sequence Number: 15624015
• Product Code: HWC
• UDI-Device Identifier: 00853114006235
• UDI-Public: (01)00853114006235(17)280929(10)300486379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200961
• 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): 01/09/2025

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 Model Number: SD21
• Device Lot Number: 300486379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2023
• 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: 47 YR
• Patient Sex: Female