RTS M30 SE010Recalls & reported problems
In2Bones USA, LLC · RTS Flexible 1st MPJ Implant with Grommets, Size 1 · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817906020007), received between Jan 22, 2026 and Jan 22, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Break
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF ANSM REFERENCE (B)(4) ON 14JAN26. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, M30 SE010, RTS FLEXIBLE 1ST MPJ IMPLANT WITH GROMMETS, SIZE 1, WHICH WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025, WHERE THE DEVICE WAS IMPLANTED INTO THE PATIENT. THEN ON (B)(6) 2026 THAT DEVICE WAS EXPLANTED BECAUSE IT NEEDED REPLACEMENT AS THE DEVICE HAD BROKEN. THE REPORT STATED THAT THE PATIENT UNDERWENT PROLONGED HOSPITALIZATION. FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, A RESPONSE HAS NOT BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SECONDARY SURGERY TO REMOVE IMPLANTED DEVICE.
Patient problems: Insufficient Information
MAUDE report 24143864 ↗
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- SWANSON G4260102Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.