DYONICS / BONECUTTER 7210486Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010494733), received between Jan 10, 2018 and Feb 25, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE BLADE WAS FOUND BROKEN. NO DELAY OR OTHER COMPLICATIONS REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. 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 11380768 ↗
• MalfunctionJan 8, 2019Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE HAD SHAVINGS THAT WERE PEELING OFF. THE METAL PIECES WERE SUCTIONED OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228702 ↗
• InjuryAug 22, 2018Material Discolored

  IT WAS REPORTED THAT THE INSIDE BLADE HAD CHANGED COLOR VERSUS THE OUTSIDE SHEATH, AS SOON AS IT WAS VISIBLE ON SCREEN AS THE DEBIDER WAS INSERTED INTO THE JOINT. ANOTHER BLADE OF SAME TYPE WAS USED, BUT ALL AVAILABLE HAD SIMILAR DISCOLORATION. PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806173 ↗
• MalfunctionJan 10, 2018Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE BLADE WAS ACTIVATED, METAL FLAKES SHED FROM THE INNER BLADE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178626 ↗