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 Code	Joint Dislocation (2374)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.We will continue to monitor and will reopen if necessary.
Event or Problem Description
Per a retrospective post-market study, it was discovered that the device, m40 se020, rts lesser mtp implant, size 2, was initially implanted on (b)(6) 2024 and it was reported due to implant dislocation, a secondary procedure on (b)(6) 2025 was required to remove the device.The complication was solved by removal of the implant.Further assessment information has been requested; however, no further information has been made available to date.This report is being raised due to the reported injury of secondary surgery for removal of an implant.

• 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: 21934659
• Report Number: 3011580264-2025-00004
• Device Sequence Number: 12069397
• Product Code: KWH
• UDI-Device Identifier: 00817906024296
• UDI-Public: (01)00817906024296
• 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
• Device Explanted 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): 04/28/2025

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 SE020
• Device Catalogue Number: M40 SE020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female