NA 72201507Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010621689), received between Aug 13, 2020 and Sep 5, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 5, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPIC PROCEDURE, THE 2.0MM FULL RADIUS POWERMINI SHAVER STOPPED WORKING AS ITS INNER SHAFT WAS BROKEN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, A 2.9 MM POWERMINI INCISOR. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146672 ↗
• MalfunctionJun 17, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FULL RADIUS BLADE STOPPED ROTATING AFTER ABOUT 10 MINUTES OF USE. AFTER CHECKING THE BLADE, IT WAS NOTICED THAT THE INNER BLADE BROKE INTO PIECES. THE BROKEN PIECES DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN UNKNOWN DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739654 ↗
• InjuryApr 4, 2022Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE FULL RADIUS BLADE CREATED METAL FLAKE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14005700 ↗
• MalfunctionAug 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS IS DUST IN THE PACKAGE. IT WAS FOUND BY THE DISTRIBUTOR THEREFORE NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10403265 ↗