Formula 0380545100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327055030), received between Jan 29, 2020 and Jul 2, 2025 — classified as 4 malfunctions.

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.

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.

• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SURGEON WAS USING AN ARTHROSCOPIC SHAVER BLADE DURING A RIGHT KNEE ARTHROSCOPY. THE SURGEON NOTED TINY METAL FRAGMENTS ON THE MONITOR INSIDE THE PATIENT'S KNEE. THE SURGEON DETERMINED THE METAL FRAGMENTS WERE FROM THE SHAVER BLADE. THE SURGEON REMOVED THE SHAVER BLADE FROM THE KNEE AND A NEW SHAVER BLADE WAS USED WITHOUT FURTHER INCIDENT. THE KNEE WAS IRRIGATED AT THE END OF THE SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387627 ↗
• MalfunctionJul 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812412 ↗
• MalfunctionAug 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163118 ↗
• MalfunctionJan 29, 2020Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9645015 ↗