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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other SAW, POWERED, AND ACCESSORIES devices

All SAW, POWERED, AND ACCESSORIES devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.