NA 1806-3545SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540196637), received between Apr 9, 2021 and Apr 9, 2021 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED: "DURING THE OPERATION FOR HUMERUS, AND AFTER INSERTING THE NAIL, THE DRILLED TO INSERT THE PROXIMAL LATERAL SCREW, BUT THE TIP OF THE DRILL BROKE. IT WAS CONSIDERED THAT THE CAUSE WAS THAT THE PATIENT WAS YOUNG AND HAD GOOD BONE QUALITY. SINCE THERE ARE TWO DRILLS IN THE INSTRUMENT, THE USED ANOTHER DRILL AND THE OPE COMPLETED WITHOUT PROBLEM." ADDITIONAL INFORMATION RECEIVED: IT SEEMED THAT THE DRILL WAS IN CONTACT WITH THE GUIDE WIRE NOT THE NAIL. THERE WAS AN ERROR IN THE PROCEDURE: THE GUIDE WIRE SHOULD BE PULLED OUT FIRST THEN SHOULD DRILL. BUT THE GUIDE WIRE WAS NOT PULLED OUT AND DRILLED. THE SURGEON CONFIRMED THAT IT WAS PROCEDURE ERROR. THE TIP OF THE DRILL WAS REMOVED, AS WELL AS OTHER METAL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645687 ↗