ORTHO SOLUTIONS STERILE DRILL BITS OS200020LCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055662930726), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• MalfunctionMar 26, 2020Fracture; Fracture

  WHILE THE SURGEON WAS DRILLING WITH THE DRILL BIT IN RIGHT 1ST MTJ FUSION PROCEDURE, IT BROKE INSIDE THE PATIENT AND THE FLUTED PORTION OF THE DRILL IS EMBEDDED IN THE PATIENT'S BONE. THE SURGEON DECIDED THAT LEAVING IT IN WOULD CAUSE LESS HARM. NO ADDITIONAL PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9883035 ↗