NA 317.871Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982189899), received between Apr 26, 2022 and Aug 20, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THIS SURGERY TWO NOVELTIES ARE PRESENTED, ONE IS THAT AT THE MOMENT THE SPECIALIST PERFORMS THE BROCADE WITH THE BIT, THIS IS BROKEN, THEN PROCEEDS TO REMOVE THE FRAGMENTS OF THIS BIT AND ANOTHER DRILL BIT WAS, THUS AVOIDING ALSO DISCOMFORT TO THE SPECIALIST. THIS REPORT INVOLVES ONE (1) 2.4MM DRILL BIT/MINI QC/80MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005457 ↗
• MalfunctionApr 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE DRILL BIT BROKE WHILE SURGEON WAS DRILLING THE BONE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) DRILL BIT Ø2.4 L80/66 2FLUTE. THIS IS REPORT 3 OF 4 FOR COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209649 ↗