MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY; SCREW

Model Number	SK19
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, the hardware had loosened and a broken screw was discovered via radiographic image during a post-op follow-up.No other patient outcomes were reported as a result of this event.The device was not returned for evaluation as it currently remains implanted in the patient.Additional information indicates the hardware may potentially be removed at a later date.The patient is currently in normal shoes with arch support and experiences pain when on her feet and when elevating her feet.The device history records for kits used in this case were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, the device was likely subjected to excessive bending stresses which resulted in its breakage.The company will supplement the mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2026-00030.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, the hardware had loosened and a broken screw was discovered via radiographic image during a post-op follow-up.No other patient outcomes were reported as a result of this event.All hardware currently remains implanted.Although there has been no injury reported and this malfunction has not resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed and replaced during a recent revision surgery due to pain, swelling, loosened and broken hardware.The revision surgery was approximately three weeks prior to (b)(6) 2026, however the exact date is unknown.The hardware had loosened and a broken screw was discovered via radiographic image during a post-op follow-up.The patient reported that she subsequently developed hammer toes of the 2nd, 3rd, and 4th toes, and experienced pain when putting on shoes and if on the foot for more than an hour.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) 2025, the hardware had loosened and a broken screw was discovered via radiographic image during a post-op follow-up.No other patient outcomes were reported as a result of this event.The device was not returned for evaluation as it currently remains implanted in the patient.Additional information indicates the hardware may potentially be removed at a later date.The patient is currently in normal shoes with arch support and experiences pain when on her feet and when elevating her feet.The device history records for kits used in this case were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, the device was likely subjected to excessive bending stresses which resulted in its breakage.The company will supplement the mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2026-00030.

• Brand Name: LAPIPLASTY
• 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, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 24450010
• Report Number: 3011623994-2026-00031
• Device Sequence Number: 13299088
• Product Code: HWC
• UDI-Device Identifier: 00853114006075
• UDI-Public: (01)00853114006075(17)290207(10)118619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: SK19
• Device Lot Number: 118619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: Female