DYONICS POWERMINI 72201509Recalls & reported problems
Smith & Nephew, Inc. · DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010621665), received between Jun 28, 2018 and Apr 13, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Flaked1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE FULL RADIUS BLADE SUDDENLY BROKE. THE DOCTOR QUICKLY REMOVED THE BROKEN PART. THE PROCEDURE WAS COMPLETED WITH A SN EQUIVALENT DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867178 ↗MalfunctionJul 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DOCTOR OBSERVED THAT SHE LEFT A METAL BURR ON THE PATIENT'S JOINT, THE DOCTOR REQUESTED THAT THE DISPOSABLE BLADE BE REPLACED AND WASHED THE JOINT TO REMOVE THE METAL BURRS, NONE FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721328 ↗MalfunctionApr 22, 2019Break
IT WAS REPORTED THAT THE SHAFT BROKE DURING SURGERY BUT NOT INSIDE THE PATIENT. NO PATIENT INJURY OR DELAYS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SINCE NO BACKUP DEVICE WAS AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8538412 ↗MalfunctionJun 28, 2018Flaked
IT WAS REPORTED THAT THE BLADE HAS LEFT SOME METAL FLAKES INTO THE JOINT. THE JOINT HAS BEEN CLEANED UP. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 7646409 ↗
Other SAW, POWERED, AND ACCESSORIES devices
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- NA 72201500Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES136 reports
- PLATINUM 72205321Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES118 reports
- Zimmer Biomet™ 89-8509-450-60Zimmer Surgical SA · Saw, Powered, And Accessories83 reports
- NA 72200617Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES77 reports
- NA 72202530Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES53 reports
- DYONICS INCISOR 72203013Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES46 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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