NA 310.111Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982185921), received between Aug 17, 2017 and Oct 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT DURING A LEFT THUMB METACARPOPHALANGEAL (MP) JOINT FUSION PROCEDURE ON (B)(6) 2018, THE DEPTH GAUGE AND DRILL BITS WERE DAMAGED. THE DEPTH GAUGE APPEARS TO BE FALLING APART, BENT AND HAS A DAMAGED DIP STICK, WHILE THE TWO (2) DRILL BITS WERE BROKEN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 1.1MM DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925697 ↗
• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT DURING A LEFT THUMB METACARPOPHALANGEAL (MP) JOINT FUSION PROCEDURE ON (B)(6) 2018, THE DEPTH GAUGE AND DRILL BITS WERE DAMAGED. THE DEPTH GAUGE APPEARS TO BE FALLING APART, BENT AND HAS A DAMAGED DIP STICK, WHILE THE TWO (2) DRILL BITS WERE BROKEN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 1.1MM DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925671 ↗
• MalfunctionAug 17, 2017Break; Break

  IT WAS REPORTED A 1.1MM DRILL BIT BROKE OFF INSIDE A 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THE DEVICES WERE DISCOVERED STUCK TOGETHER IN THE STERILE PROCESSING DEPARTMENT. NO PATIENT INVOLVEMENT WAS REPORTED. IT IS NOT KNOWN HOW OR WHEN ISSUE OCCURRED. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6800841 ↗