DYONICS 7205841SRecalls & reported problems
Smith & Nephew, Inc. · SERVICE REP CONTROL UNIT ASSEMBLY · Class 2
All models of DYONICS (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010450005), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2020Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONTROL UNIT WAS NOT DETECTING THE HANDPIECE, FOOTSWITCH WAS DETECTED BUT THE HANDPIECE HAD AN ERROR. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A PROCEDURE, IF THERE WAS A DELAY OR BACKUP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10797294 ↗
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- 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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