NA 7209700Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010475558), received between Sep 17, 2018 and Oct 30, 2018 — classified as 2 malfunctions.

3 other recalls cover devices cleared under the same FDA submission (K012314); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BLADE DID NOT PERFORM THE COAGULATION FUNCTION, WHICH CAUSED DELAY DURING THE PROCEDURE (40 MINUTES). THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMITH & NEPHEW BACKUP DEVICE (SUPER TURBOVAC). THERE WAS NO DAMAGE TO THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020693 ↗
• MalfunctionSep 17, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BLADE DID NOT DO THE COAGULATION FUNCTION. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012314. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2012 · Jul 14, 2012 · Terminated
  Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in ar
• Z-2145-2012 · Jul 14, 2012 · Terminated
  Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surg
• Z-0463-2012 · Nov 7, 2011 · Terminated
  Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.