NA 5820103010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540362407), received between Dec 17, 2019 and Feb 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fracture

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24321510 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200496 ↗
• MalfunctionFeb 14, 2023Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT 0700220000-2023-8011 THAT THE WIRE PASS DRILL BIT BROKE IN HALF DURING A SURGICAL PROCEDURE, ALL PIECES WERE ACCOUNTED FOR AND RETRIEVED, AN X-RAY WAS NEEDED AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370776 ↗
• MalfunctionDec 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A WIRE PASS DRILL BROKE AT THE TIP. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483240 ↗