NA 1796-5040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540399731), received between Apr 24, 2017 and Nov 27, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 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.

• MalfunctionNov 27, 2019Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Difficult or Delayed Positioning; Device Difficult to Setup or Prepare

  CUSTOMER REPORTED THE FOLLOWING EVENT: "WHEN INSTALLING GAMMA NAILS, IT IS IMPOSSIBLE TO INSERT THE DISTAL SCREW THROUGH THE NAIL. AFTER SEVERAL ATTEMPTS TO CHANGE THE SCREW, THE SCREW HEAD IS DAMAGED BUT LOOKS DIFFERENT FROM THE NEW ONE AS WELL AS THE SCREW PITCH. THE SECOND IS INSERTED WITHOUT ANY DIFFICULTIES".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387576 ↗
• MalfunctionApr 24, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT WHEN CUSTOMER OPENED A PACKAGE OF A STAINLESS STEEL SCREW IT WAS NOTICED THAT THE PACKAGE CONTAINED A DIFFERENT PRODUCT (TITANIUM SCREW K0C971B).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6517298 ↗