NA 357.792Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982196637), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE LOCKING BOLT MEASURING DEVICE 16 TO 80 WAS SUPPOSED TO HAVE A SILVER BALL THAT HELPS THE SLEEVE SLIDE, WHILE ALSO KEEPING THE SLEEVE FROM SLIDING ALL THE WAY OFF THE PROBE PORTION. THIS DEPTH GAUGE WAS FOUND MISSING THAT SILVER BALL. IT WAS OBSERVED AT STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497052 ↗