GAMMA 8425-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327479515), received between Mar 20, 2025 and Mar 23, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 28, 2025Class IIOpen, Classified

   Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

   Z-1914-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Fracture

  AS REPORTED: "THE DISTRIBUTOR CONTACTED THE SALES REPRESENTATIVE TO REPORT THAT A GAMMA4 NAIL USED ON A PATIENT HAD BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670110 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "DURING INSERTION OF A GAMMA 4 LONG NAIL FOR A SUBTROCHANTERIC FEMORAL FRACTURE, THE NAIL TIP PERFORATED THE ANTERIOR ASPECT OF THE FEMUR AT THE UPPER FEMORAL CONDYLE. THE ENTRY WAS REPOSITIONED ANTERIORLY AND THE NAIL WAS REINSERTED DEEPLY. THE SURGERY WAS COMPLETED. THE DEVICE IS IMPLANTED IN THE PATIENT'S BODY".

  Patient problems: Insufficient Information

  MAUDE report 23783832 ↗
• MalfunctionMar 20, 2025Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  AS REPORTED: "OPENED THE RIGHT NAIL OF GAMMA 4 DIAMETER 10MM / LENGTH 320MM. LUG SCREW INTERFERENCE CHECK WAS PERFORMED. AFTER INSERTING THE NAIL AND LAG SCREW, THE DISTAL DEVICE WAS ATTACHED, AND AFTER ADJUSTING THE HEIGHT, THE MOST DISTAL CIRCULAR HOLE WAS DRILLED, BUT AFTER PASSING THROUGH THE FRONT HOLE, THE DRILL DID NOT PASS THROUGH DUE TO INTERFERENCE INSIDE THE NAIL. AFTER THAT, WE TRIED THE DISTAL MOST ROUND HOLE AND THE ELLIPTICAL HOLE, BUT THE DRILLS DID NOT PASS THROUGH ALL OF THEM. WHEN THE C-ARM WAS INSERTED FROM RIGHT BESIDE THE DISTAL END OF THE NAIL TO SWITCH TO RADIOLUCENT, IT WAS DISCOVERED THAT THE CUT SURFACE AT THE DISTAL END OF THE NAIL WAS NOT FORWARD, BUT BACKWARD. AFTER REMOVING THE NAIL, A NAIL ONE SIZE SHORTER (300 MM) WAS REINSERTED. SURGERY WAS COMPLETED. AFTER SURGERY, THE DISTAL DEVICE AND NAIL WERE INSTALLED AND CALIBRATED, AND THE DRILL DID NOT PASS".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21659994 ↗