Olive Wire 1405-2266Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810111221191), received between Apr 14, 2023 and Apr 14, 2023 — 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. 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.

• MalfunctionApr 14, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF AN OLIVE WIRE DRILL BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH, THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Foreign Body In Patient

  MAUDE report 16747961 ↗