NA 310.632Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982186836), received between Feb 16, 2023 and Apr 25, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGERY WAS AN OPEN ELBOW OPEN-REDUCTION DRILL FIXATION USING A 6.5MM CANNULATED SCREW OVER GUIDEWIRE WHICH IS USED IN A 19-YEAR-OLD PATIENT. THE 5MM CAME IN THE DRILL BIT THAT WAS USED, WOULD NOT PASS OVER IN THE COMPLETE GUIDE WIRE DURING THE CASE. THE LARGER DRILL BIT IN THE SET WAS USED. THE 5MM DRILL BIT WAS NOT USED IN THE CASE AND NOT DIRECTLY INVOLVED IN THE PATIENT. UPON INSPECTION, AFTER THE CASE, NO GUIDEWIRE HAS PASSED THROUGH THE 5MM DRILL BIT AND THERE IS NO OBSTRUCTION WITHIN THE DRILL BIT ITSELF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED DRILL BIT/QC 200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16810902 ↗
• MalfunctionFeb 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT THERE WAS STILL DIRT IN THE TWO (2) CANNULATED DRILL BITS. IT WAS FOUND BEFORE THE PROCEDURE, BEFORE STERILIZATION IN THE HOSPITAL. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED DRILL BIT/QC 200MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388057 ↗