NA 315.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982189196), received between Sep 14, 2020 and Sep 14, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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.

• MalfunctionSep 14, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE THREE (3) 2.5 MM THREE-FLUTED DRILL BITS WERE DULL. THE PATIENT HAD A HARD BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 MM THREE-FLUTED DRILL BIT QC/110 MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530061 ↗
• MalfunctionSep 14, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE THREE (3) 2.5 MM THREE-FLUTED DRILL BITS WERE DULL. THE PATIENT HAD A HARD BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 MM THREE-FLUTED DRILL BIT QC/110 MM THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530025 ↗
• MalfunctionSep 14, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE THREE (3) 2.5 MM THREE-FLUTED DRILL BITS WERE DULL. THE PATIENT HAD A HARD BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 MM THREE-FLUTED DRILL BIT QC/110 MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529986 ↗