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

Model Number	M40 SE020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be provided upon additional details surrounding the revision surgery.
Event or Problem Description
On (b)(6) 2025, in2bones usa was informed that the device, m40 se020, rts lesser mtp implant, size 2, was initially implanted on (b)(6) 2024 and it was reported that due to implant breakage a secondary procedure has been scheduled for (b)(6) 2025.This report is being raised due to the reported injury of secondary surgery for the removal of the implant.
Event or Problem Description
Supplemental mdr: additional information was received regarding the patient.On (b)(6) 2025 the patient had revision surgery with the device, m40 se030, rts lesser mtp implant, size 3.It was further reported that the patient experienced pain and swelling after the initial surgery and was compliant with post-op care instructions.

• Brand Name: RTS
• Common Device Name: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): IN2BONES USA; 7750a trinity road; cordova TN 38018
• Manufacturer (Section G): IN2BONES USA; 7750 trinity road; cordova TN 38018
• Manufacturer Contact: darby eime ; 7750a trinity road; cordova, TN 38018
• MDR Report Key: 22903835
• Report Number: 3011580264-2025-00010
• Device Sequence Number: 8001046
• Product Code: KWH
• UDI-Device Identifier: 00817906024296
• UDI-Public: (01)00817906024296(17)280803(10)RK29444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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
• Device Model Number: M40 SE020
• Device Catalogue Number: M40 SE020
• Device Lot Number: RK29444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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 Sex: Unknown