T2 1822-0828SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540197610), received between Feb 13, 2019 and Feb 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2019Difficult to Remove; Patient-Device Incompatibility

  THE SURGEON REPORTED THAT HE WAS UNDERTAKING A 2 STAGE REVISION OF KNEE AND DECIDED TO USE A GAMMA NAIL AS A SPACER. DURING THE CASE HE INSERTED THE NAIL AND WHEN HE INSERTED ONE OF THE SCREWS IT WAS THE WRONG SIZE. THE SCREW WAS NOT FULLY SEATED AND WHEN THE SURGEON TRIED TO REMOVE IT, IT COLD WELDED ITSELF ONTO THE NAIL. THE SURGEON LEFT THE NAIL AND SCREW IN SITU. THE REPORTED EVENT RESULTED IN A 2 HOUR DELAY TO SURGERY AND THE SURGEON WAS CONCERNED ABOUT THE RISK OF INFECTION DUE TO THE LENGTH OF TIME THE PATIENT WAS ON THE TABLE.

  Patient problems: No Code Available

  MAUDE report 8337604 ↗