NA 702448Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540112026), received between Jan 17, 2019 and May 28, 2026 — classified as 2 malfunctions.

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

• MalfunctionMay 28, 2026Crack; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, A CANNULATED DRILL BIT FOR THE ASNIS 4.0 BROKE OFF IN THE BONE AROUND THE ACCOMPANYING GUIDE PIN; THE TIP SPLIT OPEN LIKE A FLOWER PETAL. THE BROKEN FRAGMENT DID NOT REMAIN IN THE PATIENT'S BONE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325303 ↗
• MalfunctionJan 17, 2019Break; Fracture; Unintended Collision; Fracture

  PRIMARY LEFT LAPIDUS BUNIONECTOMY. IT WAS REPORTED THAT TWO 2.0 DRILL BITS BROKE WHEN THEY HIT PREVIOUSLY IMPLANTED SCREWS. DURING BONE FENESTRATION, A 1.4 DRILL BIT BROKE IN PATIENT'S BONE (NO CONTACT WITH ANY DEVICES). PATIENT'S BONE QUALITY WAS NORMAL. A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS CAUSED DUE TO THE NEED TO REMOVE THE BROKEN PORTION OF THE BITS, PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258988 ↗