Speed DK-265-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633020630), received between Jun 27, 2018 and Jun 27, 2018 — 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.

• MalfunctionJun 27, 2018Break; Break

  IT WAS REPORTED THAT DURING A PODIATRY PROCEDURE ON (B)(6) 2018, THE DRILL BIT FROM THE 2.65MM DRILL KIT (DK) BROKE. WHILE USING THE STERILE DRILL KIT TO IMPLANT BME SPEED TITAN STAPLES, THE DRILL BIT IN THE KIT BROKE INTO TWO PIECES WHILE THE DOCTOR WAS DRILLING. BOTH FRAGMENTS WERE EASILY RECOVERED WITHOUT ADDITIONAL MEDICAL INTERVENTION AND THE DOCTOR WAS ABLE TO PROCEED WITH THE PROCEDURE BY OPENING ANOTHER STERILE 2.65 MM DRILL KIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR A SPEED SHIFT/TITAN DRILL KIT S-265QD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641681 ↗