FMS 287869Recalls & reported problems
Depuy Mitek, LLC · FMS BARREL BURR PLUS 5.0mm FOR USE with FMS DUO+ System · Class 2
All models of FMS (9)
Data updated Oct 16, 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 10886705023097), received between Jun 18, 2018 and Aug 24, 2018 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Break; Break
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING KNEE ARTHROSCOPY, IT WAS OBSERVED THAT THE PART WHICH ROTATES INSIDE THE BARREL BURR PLUS, 5.0MM CROSSCUT-TORNADO HUB DEVICE HEATED UP AND BROKE DOWN. IT WAS REPORTED THAT THE EVENT OCCURRED OUTSIDE THE PATIENT. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7813725 ↗MalfunctionJun 18, 2018Mechanical Jam; Mechanical Jam
DURING ARTHROSCOPY BURR GOT STUCK AND COULD NOT BE USED ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7609435 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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