MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY SYSTEM 4A ANATOMIC MULTIPLANAR IMPLANTS; PLATE

Model Number	SK39
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, the patient is experiencing swelling in the arch area.Ct images from a post-op follow-up show a non-union and two broken screws.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, a 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) 2023, the patient is experiencing swelling in the arch area.Ct images from a post-op follow-up show a non-union and two broken screws.No other patient outcomes were reported as a result of this event.No devices were returned for evaluation as they remain 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, the broken screws were likely subjected to excessive bending stresses which resulted in their breakage and contributed to the nonunion.The company will supplement the mdr as necessary and appropriate.
Additional Manufacturer Narrative
Updated fields: b5: additional information was received on 10/17/2024 indicating pain was also experienced.G3: date received by manufacturer: 10-17-2024.G6: type of report: 30-day follow-up.H2: if follow-up, what type: additional information.H6: health effect clinical code- 1994 pain.H11: additional information was received on 10/17/2024 indicating pain was also experienced and the current status of the patient is they are wearing a boot, using a bone stimulator, and taking prescription calcium to help with bone fusion which has not yet occurred.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
Additional information was received on 10/17/2024 indicating pain was also experienced.

• Brand Name: LAPIPLASTY SYSTEM 4A ANATOMIC MULTIPLANAR IMPLANTS
• Common Device Name: PLATE
• 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: 20467826
• Report Number: 3011623994-2024-00186
• Device Sequence Number: 18010388
• Product Code: HRS
• UDI-Device Identifier: 00853114006327
• UDI-Public: (01)00853114006327
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK39
• Device Lot Number: 300437107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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
• Patient Sex: Female