NA 03.130.312Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982075628), received between Mar 19, 2026 and Mar 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 18, 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.

• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640368 ↗
• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640347 ↗