NA 26208SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551274736), received between Jan 16, 2024 and Jan 16, 2024 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT TWO NEW BLADES BROKE AS SOON AS DRILLCUT WAS STARTED. IN THIS CASE, IT WOULD HAVE BEEN POSSIBLE FOR A PIECE OF THE BLADE TO HAVE ENDED UP INSIDE THE PATIENT. FORTUNATELY, THIS DID NOT HAPPEN WHEN THE BLADE WAS OUTSIDE THE PATIENT WHEN THE PIECE CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519522 ↗
• MalfunctionJan 16, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT TWO NEW BLADES BROKE AS SOON AS DRILL CUT WAS STARTED. IN THIS CASE, IT WOULD HAVE BEEN POSSIBLE FOR A PIECE OF THE BLADE TO HAVE ENDED UP INSIDE THE PATIENT. FORTUNATELY, THIS DID NOT HAPPEN WHEN THE BLADE WAS OUTSIDE THE PATIENT WHEN THE PIECE CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519520 ↗