NA 1796-5045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540399748), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 injury.

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. 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.

• InjuryJun 12, 2019Break

  IT WAS REPORTED BY THE SALES REP THAT " LONG GAMMA NAIL BROKE ABOVE THE CERVICAL SCREW. BROKEN NAIL WAS REPLACED WITH THE HUMERAL HEAD. FEEDBACK FROM THE CUSTOMER RECEIVED ON APRIL 8TH 2019 : "THE LONG GAMMA NAIL INCRIMINATED IN THIS MATERIAL VIGILANCE WAS PLACED ON (B)(6) 2016. THE SURGEON DECIDED TO REOPEN ON (B)(6) 2019 BECAUSE THE PATIENT WAS DELAYED IN CONSOLIDATION. DURING THIS SECOND OPERATION, THE SURGEON DISCOVERED THAT THE NAIL WAS BROKEN IN ITS PROXIMAL PART AND THE DISTAL SCREW, AND REVIVED THE BONE AND PLACED ANOTHER NAIL.

  Patient problems: No Code Available

  MAUDE report 8691118 ↗