NA 310.24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982186287), received between Aug 30, 2022 and Mar 13, 2024 — classified as 3 malfunctions.

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

• MalfunctionMar 13, 2024Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, THE DRILL BIT IN QUESTION FRACTURED. THE FRAGMENTS GENERATED WERE ABLE TO BE REMOVED WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY USING A SECOND DRILL BIT OF THE SAME TYPE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/JC/GOLD/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893604 ↗
• MalfunctionAug 2, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN UNKNOWN PROCEDURE THE DRILL BITS IN QUESTION WERE FOUND TO BE BLUNT. THEIR PASSAGE THROUGH THE BONE WAS DELAYED, THE DRILL BITS DID NOT CUT AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/JC/GOLD/95MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439848 ↗
• MalfunctionAug 30, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL. THIS CAUSED A DELAY TO THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 2.5MM DRILL BIT/JC/GOLD/95MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323872 ↗