DYONICS 72205106Recalls & reported problems
Smith & Nephew, Inc. · 3.5MM INCISOR PLUS PLATINUM BLADE · Class 1
- 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 00885556708873), received between Jan 19, 2024 and Oct 17, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Flaked1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Flaked; Flaked
IT WAS REPORTED THAT DURING A SURGERY, WHEN USING A 3.5 MM INCISOR BLADE, THE DOCTOR OBSERVED TINY METAL PARTICLES FLOATING AROUND AND EXPRESSED CONCERN ABOUT THE QUALITY OF THE BLADE. THE METAL PARTICLES WERE REMOVED USING SUCTION AND SALINE FLUSH. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS HEALTHY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324460 ↗MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE EXTERNAL SLEEVE OF ONE INCISOR PLUS PLAT BLADES WERE COMING OUT WHILE IN USE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22145342 ↗MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE EXTERNAL SLEEVE OF TWO (2) INCISOR PLUS PLAT BLADES WERE COMING OUT WHILE IN USE. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090494 ↗MalfunctionJan 19, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING SET UP FOR A KNEE ARTHROSCOPY, THE PACKAGE OF THE INCISOR PLUS PLAT BLADE WAS BROKEN. THERE WAS A BACK-UP DEVICE AVAILABLE AND A SURGICAL DELAY OF LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543648 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.