NA 310.28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186379), received between Jan 23, 2023 and Jan 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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.

• MalfunctionJan 23, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2023, THE TIP OF A 4.0 CANNULATED SCREW DRIVER HAD BROKEN OFF. IT WAS LATER DETERMINED THAT THE SCREW DRIVER WAS ONLY ROUGHED UP. ADDITIONALLY, BOTH THE 2.0 AND 2.7 DRILL BITS DULLED QUICKLY. THERE WERE NO FRAGMENTS GENERATED AND THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 2.7MM DRILL BIT/QC/125MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230023 ↗