MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY LESSER TMT FIXATION PACK; SCREW

Model Number	SK28
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, the patient is experiencing a potential non-union, and has pain and swelling at the first tmt joint.Radiographic images from a post-op follow-up shows a screw is backing out of the plate.No other patient outcomes were reported as a result of this event.Additional information indicates the surgeon was concerned that the patient had been too aggressive with weight bearing after transitioning to an athletic shoe 6 weeks post-op.The device was not returned for evaluation as it currently remains implanted in the patient with no scheduled plans to revise.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 the backing out of the screw, it is likely that patient non-compliance contributed to what was reported.The company will supplement the mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in 3011623994-2024-00128.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, the patient is experiencing a potential non-union, and has pain and swelling at the first tmt joint.Radiographic images from a post-op follow-up shows a screw is backing out of the plate.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.

• Brand Name: LAPIPLASTY LESSER TMT FIXATION PACK
• 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: 19737146
• Report Number: 3011623994-2024-00129
• Device Sequence Number: 3569201
• Product Code: HWC
• UDI-Device Identifier: 00853114006204
• UDI-Public: 00853114006204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• 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): 07/13/2024

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: SK28
• Device Lot Number: 300427053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: Male