MAUDE Adverse Event Report: IN2BONES USA RTS; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Model Number	M40 SE030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a retrospective post-market study, it was discovered that the device, m40 se030, rts lesser mtp implant, size 3, was initially implanted on (b)(6) 2025.It was reported that due to an infection from the implant a secondary procedure was required to remove the device.The complication was solved by removal of the implant and cleaning of the articulation and implanting a new m40 se030, rts lesser mtp implant, size 3.

• Brand Name: RTS
• Common Device Name: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): IN2BONES USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer (Section G): IN2BONES USA; 6000 poplar avenue; suite 115; memphis TN 38119
• Manufacturer Contact: darby eime ; 6000 poplar avenue; suite 115; memphis, TN 38119 ; 9012607931
• MDR Report Key: 22017971
• Report Number: 3011580264-2025-00006
• Device Sequence Number: 12925638
• Product Code: KWH
• UDI-Device Identifier: 00817906024302
• UDI-Public: (01)00817906024302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173491
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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?: No
• Device Model Number: M40 SE030
• Device Catalogue Number: M40 SE030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Male