NA 310.21SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186218), received between May 16, 2023 and May 16, 2023 — classified as 1 injury.

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

• InjuryMay 16, 2023Break; Entrapment of Device; Break; Entrapment of Device

  AT APPROXIMATELY 1420, IT WAS REPORTED THAT ON (B)(6) 2023 DURING A HANDOFF THAT A 2.0MM DRILL BIT, WAS BROKEN OFF INTO THE PATIENT. IT WAS REPORTED THAT THIS OCCURRED RIGHT BEFORE HAND OFF BEGAN. THE SURGICAL TEAM DECIDED THAT TO FURTHER ATTEMPT TO REMOVE THE DRILL BIT WOULD CAUSE MORE DAMAGE TO THE PATIENT THAN TO LEAVE IT. APPROXIMATELY 25MM REMAINS IN THE PATIENT. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/125MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16939460 ↗