EVOS 71174905Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556386545), received between Apr 11, 2021 and Jun 6, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING USE, THERE WAS A QUALITY FAILURE OF THE 1.8MM DRILL SHORT W/AO QC OF THE EVOS SYSTEM. IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED OR IF THERE WAS A DELAY DUE TO THIS EVENT. NO PATIENT COMPLICATIONS REPORTED. AS PER INVESTIGATION RESULTS, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS CHIPPED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611388 ↗
• MalfunctionApr 11, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN A STERILE 1.8MM DRILL SHORT W/AO QC WAS OPENED FROM THE INSIDE PACKAGING HAD BEEN PIERCED BY THE DRILL BIT, CONSEQUENTLY MAKING IT UNSTERILE. IT WAS NOTICED THAT THE PROTECTIVE ENDS HAD COME LOOSE FROM THE DRILL IN TRANSIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646833 ↗