GAMMA 8425-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327479409), received between Mar 25, 2025 and May 12, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Positioning Failure; Device Damaged by Another Device

  AS REPORTED: "DURING DISTAL DRILLING, THE DRILL BIT WAS SLIGHTLY IN CONTACT WITH THE NAIL; THE DRILL TIP BROKE OFF THE MOMENT THE DEVICE WAS LOWERED FORCEFULLY. THE BROKEN DRILL TIP HAS BEEN REMOVED, SO THERE ARE NO FOREIGN BODIES REMAINING IN THE BODY." ADDITIONAL INFORMATION RECEIVED FROM SALES REP: HOW WAS THE ISSUE SOLVED? ANOTHER DRILL BIT WAS PROVIDED, AND THE ISSUE WAS RESOLVED BY MAKING MINOR ADJUSTMENTS TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153054 ↗
• InjuryOct 20, 2025Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2025, THE PATIENT FELT PAIN IN MY FEMUR. AN X-RAY REVEALED A NAIL FRACTURE."

  Patient problems: Pain

  MAUDE report 23342465 ↗
• InjuryJul 25, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2024, A GAMMA 4 IMPLANT WAS INSERTED FOR A TROCHANTERIC FRACTURE. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF PAIN, AND AN X-RAY REVEALED THAT THE NAIL (IN THE LAG SCREW HOLE AREA) WAS BROKEN. THE DOCTOR BELIEVES THAT THE NAIL WAS UNDER STRESS DUE TO NONUNION. REOPERATION (BHA) IS SCHEDULED FOR (B)(6) 2025."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22610289 ↗
• MalfunctionMar 25, 2025Device Damaged by Another Device; Material Deformation; Positioning Problem; Device Damaged by Another Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT: "THE SURGERY WAS PERFORMED TO IMPLANT THE T2 ALPHA NAIL FOR A PATIENT WITH RIGHT SUBTROCHANTERIC FRACTURE. WHEN THE PRECISION PIN WAS INSERTED, IT INTERFERED WITH THE NAIL. AFTER THAT, THE NAIL PASSED THROUGH, BUT THE LAG SCREW REAMER DID NOT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRECISION PIN WITH ANOTHER ONE AND REPLACING THE NAIL WITH 360 MM NAIL BECAUSE THEY WERE DAMAGED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692893 ↗