NA 317.861Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982189851), received between Nov 16, 2022 and Nov 16, 2022 — 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.

• InjuryNov 16, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS DISCOVERED THAT ON (B)(6) 2022, ITEM 317.861 SPLIT IN THE MIDDLE OF SURGERY AND COULD NOT BE EXTRACTED. IT REMAINED IN THE PATIENT¿S BONE. ITEM 292.120.01 WAS SCRATCHED AND WAS NOT USED IN SURGERY. THIS DID NOT AFFECT THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.8MM DRILL BIT/MINI QC/80MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15809893 ↗