NA 310.161Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186089), received between Feb 22, 2018 and Feb 22, 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. 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.

• MalfunctionFeb 22, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, THE 1.5MM DRILL BIT BROKE. THE FRAGMENT WAS COMPLETELY REMOVED. IT IS UNKNOWN IF THERE WAS A BACK-UP SIMILAR DEVICE FOR THE SURGEON TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THIS MALFUNCTION RESULTED IN SURGICAL DELAY. REPORTEDLY, THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288932 ↗