NA 310.111SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982185938), received between Apr 21, 2021 and Apr 21, 2021 — 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. 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.

• MalfunctionApr 21, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6),2021 DURING THE FIXATION OF HAND BONES THE SURGEON NOTICED THE 2ND DRILL BIT WAS BLUNT WHILE DRILLING THE 5TH SCREW HOLE. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MINI QC/55MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703664 ↗