NA 390016SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540430298), received between Nov 9, 2017 and Nov 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• MalfunctionNov 9, 2017Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT THE SURGEON, WAS USING A 6.5 ASNOS SCREW AND THE HEAD OF THE SCREW WENT STRAIGHT THROUGH THE WASHER. THE CASE WAS COMPLETED SUCCESSFULLY, ALTHOUGH THE SCREW WAS LEFT WITHOUT A WASHER. THERE WAS A FEW MINUTES DELAY WHILE THE SCREW WAS REMOVED FROM THE PATIENT - THIS WAS AN ASNIS 6.5 HIP SCREW DONE PERCUTANEOUSLY SO DIFFICULT TO RETRIEVE FROM SMALL INCISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7015146 ↗