NA 5300010059Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153000013), received between Aug 17, 2020 and Aug 17, 2020 — classified as 2 malfunctions.

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

• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE , TWO DRILL BITS BROKE. IT WAS ALSO REPORTED THAT THERE WAS A FIVE TO TEN MINUTE DELAY AS A RESULT OF THIS EVENT TO GET A BACK-UP DEVICE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST DRILL BIT THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10414573 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO DRILL BITS BROKE. IT WAS ALSO REPORTED THAT THERE WAS A FIVE TO TEN MINUTE DELAY AS A RESULT OF THIS EVENT TO GET A BACK-UP DEVICE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.THIS REPORT IS FOR THE SECOND DRILL BIT THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10414566 ↗