GAMMA 8225-2240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327593747), received between Jun 23, 2026 and Sep 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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.

• MalfunctionSep 21, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841125 ↗
• InjuryJun 23, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO A FAILURE TO CHECK PROPERLY, THE SALES REP OPENED THE NAIL FOR THE OPPOSITE SIDE BY MISTAKE, AND BY THE TIME THE PHYSICIAN REALIZED IT, IT HAD BEEN ALREADY INSERTED THE FIRST DISTAL CROSS-PIN, FISSURE FRACTURE WAS CONFIRMED. INCOMPLETE FRACTURE AT THE TIP CAUSED BY THE INSERTION OF A NAIL ON THE OPPOSITE SIDE. THERE ARE NO PLANS TO REPLACE IT WITH A LONG NAIL, AND REHABILITATION IS REPORTEDLY PROGRESSING SMOOTHLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25595835 ↗