NA 1806-4270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196804), received between Oct 9, 2021 and Feb 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "THE END PORTION OF THE DRILL BIT FOR THE DISTAL LOCKING SCREW DURING A SHORT GAMMA NAIL CASE WAS STRIPPED AND BROKE OFF INSIDE PATIENT'S FEMUR BONE".

  Patient problems: Foreign Body In Patient

  MAUDE report 21417488 ↗
• MalfunctionOct 9, 2021Break; Fracture; Break; Fracture

  THE FOLLOWING WAS REPORTED VIA MEDWATCH (B)(4): A STRYKER DRILL BIT BROKE AND WITHIN THE BODY OF THE MEDIAL CALCANEUS DURING THE PROCEDURE. THE DRILL BIT WAS NOTED TO BE WITHIN THE SUBSTANCE OF THE BONE AND WAS LEFT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12601906 ↗