Formula 0380545150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327055047), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SHAVER STOPPED FUNCTIONING DURING A KNEE ARTHROSCOPY PROCEDURE. AT THE TIME, THE SURGICAL TEAM WAS UNAWARE THAT THE BLADE HAD FRAGMENTED. THE TECHNICIAN LATER RECALLED THE DEVICE HAD BEEN PRODUCING AN UNUSUAL SOUND FOR SEVERAL MINUTES PRIOR TO REPLACEMENT. THE MISSING BLADE FRAGMENT WAS DISCOVERED AFTER THE PROCEDURE WAS COMPLETED AND THE PATIENT HAD BEEN TRANSFERRED TO RECOVERY. THE INITIAL PROCEDURE WAS COMPLETED. HOWEVER, THE PATIENT REQUIRED AN IMMEDIATE RETURN TO SURGERY FOR RETRIEVAL OF THE BLADE FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560467 ↗