NA 7205316Recalls & reported problems
Smith & Nephew, Inc. · 4.5 MM TURBOWHISKER STRAIGHT BLADES, POWER/EP-1, NAVY BLUE, PACKAGED 6 PER BOX, STERILE · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010251442), received between Aug 27, 2025 and Nov 24, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Delivered as Unsterile Product1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Break; Break
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, A PIECE OF METAL FROM THE 4.5 MM TURBOWHISKER BLADE WAS STUCK IN THE PATIENT'S KNEE CARTILAGE. IT IS UNKNOWN IF THERE WAS A S+N BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23632889 ↗MalfunctionAug 27, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT ALL SIX (6) BLADES IN THE TURBOWHISKER BLADE BOX WERE DAMAGED; THERE WERE HOLES IN THE PACKAGE. THE MALFUNCTION WAS FOUND DURING UNBOXING; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901559 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.