FMS 283255Recalls & reported problems
Medos International Sàrl · FMS 3.0mm Mini Round Tornado Burr Plus · Class 2
All models of FMS (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705000784), received between Jan 30, 2019 and Jan 30, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
- Not Applicable2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2019Break
IT WAS REPORTED DURING AND UNKNOWN PROCEDURE THE TWO BURRS BROKE UNDER THE THREADED TOP. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WAS A 5-MINUTE DELAY IN SURGERY AND NO PATIENT CONSEQUENCE. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 8291038 ↗MalfunctionJan 30, 2019Break
IT WAS REPORTED DURING AND UNKNOWN PROCEDURE THE TWO BURRS BROKE UNDER THE THREADED TOP. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WAS A 5-MINUTE DELAY IN SURGERY AND NO PATIENT CONSEQUENCE. THIS REPORT IS 1 OF 2 FOR (B)(4). .
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 8290949 ↗
Other Arthroscope devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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