NA 309.004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982185525), received between May 15, 2023 and May 15, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS UNDERGOING A REMOVAL SURGERY FOR A DISTAL RADIUS FRACTURE WITH THE CARBIDE DRILL BIT IN QUESTION. THE DISTAL RADIUS PLATE WAS ONE MANUFACTURED BY ANOTHER COMPANY AND THE LOCKING SCREWS COULD NOT BE REMOVED, SO THE CARBIDE DRILL BIT WAS USED. DURING THIS PROCESS, THE DRILL BIT BROKE. THE EXTRACTION WAS COMPLETED USING ANOTHER CARBIDE DRILL BIT. THE SURGEON REMOVED THE METAL FRAGMENTS THAT WERE GENERATED, BUT AN X-RAY CONFIRMED THAT A SMALL PIECE OF WHAT APPEARED TO BE METAL REMAINED. IT IS DIFFICULT TO DETERMINE IF THE FRAGMENT IS FROM THE CARBIDE DRILL BIT OR THE OTHER MANUFACTURER¿S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM CARBIDE DRILL BIT STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16930686 ↗