GAMMA 8425-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327479447), received between Jun 5, 2023 and Aug 12, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Fracture

  It was reported that, after the surgery, the nail fractured and was replaced with one from another manufacturer.

  Patient problems: Insufficient Information

  MAUDE report 50227223 ↗
• InjuryJun 16, 2026Fracture

  AS REPORTED: "GAMMA4 LONG NAIL REVISION DUE TO FRACTURE AT THE LAG SCREW HOLE."

  Patient problems: Insufficient Information

  MAUDE report 25521166 ↗
• MalfunctionMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "ALS IS GRADUALLY LOOSENING UP AFTER SURGERY".

  Patient problems: Insufficient Information

  MAUDE report 21583337 ↗
• InjuryDec 10, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON REPORTS WHAT HE BELIEVES TO BE A BROKEN GAMMA 4 NAIL. THE SURGEON CLAIMS AGAIN THAT THE NAIL BROKE AT THE JUNCTION OF THE LAG SCREW. THERE HAS NOT TO DATE BEEN A RE OPERATION." UPDATE: THE PATIENT CLAIMS THEY HAD LITTLE TO NO PAIN FOR 6 MONTHS THEN SUDDENLY FELT PAIN. THE NAIL WAS EXPLANTS AND THE SURGEON IMPLANTED A TOTAL HIP REPLACEMENT.

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20897132 ↗
• InjuryJun 5, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA 4 NAIL IMPLANTED 5 MONTHS AGO. PATIENT HAD SUB-TROCH NON-UNION AND FELL, GAMMA 4 NAIL BROKE. PATIENT NEVER HEALED AND WAS ALLOWED TO 'WAIT THERE' FOR THE SURGEON AND PA." IT WAS ALSO REPORTED THAT THERE WAS AN INFECTION, AND THE PATIENT WAS REVISED.

  Patient problems: Failure of Implant; Fall; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17057006 ↗