NA 7207492Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010430007), received between Sep 6, 2023 and Sep 6, 2023 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE SURGEON PASSED THE ENDOSCOPIC DRILL, THERE WAS A POP AND IT WAS IDENTIFIED THAT THE DRILL HAD BROKEN IN THE TIP REGION, LEAVING THE BROKEN TIP INSIDE THE PATIENT. IT WAS NOT POSSIBLE TO REMOVE THE DRILL TIP FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17691600 ↗