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DYONICS 72205292Recalls & reported problems

Smith & Nephew, Inc. · 4.0MM PLATINUM FLYER BLADE · Class 1

Adverse event reports
7
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556764473), received between Mar 8, 2021 and Feb 3, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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: 0 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: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 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

  • Break3
  • Manufacturing, Packaging or Shipping Problem2
  • Dull, Blunt1
  • Flaked1
  • Material Discolored1
  • Material Twisted/Bent1
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2026Break; Material Twisted/Bent; Mechanical Jam

    IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE 4.0MM PLATINUM FLYER BLADE'S JAW WAS DEFECTIVE AS THE BLADES DID NOT FIT AND ROTATE SMOOTHLY INTO EACH OTHER. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION CONCLUDED THAT THE INNER BLADE IS DEFORMED AND FRACTURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24248750 ↗
  • MalfunctionOct 2, 2024Material Discolored; Flaked; Material Discolored; Flaked

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE 4.0MM PLATINUM BLADE´S TIP HAD A BLACK SHADOW THAT LOOKED LIKE RUST, THE DOCTOR DECIDED NOT USE THE DEVICE IN THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 5 MINUTES SURGICAL DELAY REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20351208 ↗
  • InjuryMay 23, 2022Break; Break

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE INNER LUMEN OF THE FLYER BLADE BROKE OFF INSIDE THE KNEE. THE PIECES WERE REMOVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14476207 ↗
  • InjuryJun 14, 2021Break; Break

    IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE TIP OF THE "4.0MM PLATINUM FLYER BLADE" BROKE OFF INSIDE THE PATIENT'S KNEE. THE SURGEON MANAGED TO RETRIEVE THE TOP OF THE BLADE USING A GRASPER INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11995903 ↗
  • InjuryMay 5, 2021Dull, Blunt; Dull, Blunt

    IT WAS REPORTED THAT, DURING AN ACL KNEE RECONSTRUCTION AND MENISCUS DEBRIDEMENT, THE PLATINUM FLYER BLADE 4.0MM DID NOT REMOVE THE TISSUE FROM THE MENISCUS AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH A 4.5MM INCISOR PLUS ELITE DEVICE. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED, 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 Clinical Signs, Symptoms or Conditions

    MAUDE report 11781366 ↗
  • MalfunctionMar 8, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT AN UNUSUAL PACKAGING WAS NOTICED FOR A PLATINUM FLYER BLADE. UPON FURTHER INSPECTION IT WAS REALIZED THAT STERILE SEAL WAS COMPROMISED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11440988 ↗
  • MalfunctionMar 8, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT AN UNUSUAL PACKAGING WAS NOTICED FOR A PLATINUM FLYER BLADE. UPON FURTHER INSPECTION IT WAS REALIZED THAT STERILE SEAL WAS COMPROMISED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11440962 ↗

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.