Formula 0380544150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327055009), received between Jul 17, 2018 and Mar 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A MENISCECTOMY, THE INNER SHAFT OF THE SHAVER SEEMINGLY GOT CAUGHT ONTO SOMETHING AND SNAPPED RIGHT OFF INTO THE JOINT. THERE WAS A 5 MINUTE DELAY TO FISH OUT THE BROKEN PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692123 ↗
• MalfunctionNov 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. NO BROKEN PIECES FELL WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728392 ↗
• MalfunctionJul 17, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694087 ↗