GAMMA 3525-1420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252274308), received between Sep 25, 2015 and Jul 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryJul 28, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER 6 MONTH, THE NAIL WAS REMOVED SINCE IT BROKE OFF AT THE CEPHALIC SCREW PART.

  Patient problems: Insufficient Information

  MAUDE report 22632285 ↗
• InjuryJul 27, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE. THE PATIENT REQUIRED REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 15112739 ↗
• InjuryMay 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "LONG GAMMA NAIL HAS BEEN BROKEN 2 MONTHS AFTER THE INITIAL SURGERY. NAIL HAS BEEN OPERATIVELY REMOVED."

  Patient problems: Failure of Implant

  MAUDE report 14438311 ↗
• InjuryJul 22, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL BROKE REQUIRING REVISION. MOBILISATION INSTRUCTIONS: MOBILISATION AS TOLERATED. PATIENT MOBILISED WELL WITH STICK AFTER BEING DISCHARGED FROM PRIMARY OP. USES STICK SOMETIMES WHEN OUTSIDE BUT DOES NOT USE STICK INDOORS. NO TRAUMA.

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

  MAUDE report 10310995 ↗
• InjurySep 25, 2015Break; Noise, Audible

  IT WAS REPORTED VIA THE FDA UF #(B)(4), THAT "STRYKER GAMMA NAIL PLACED EARLIER THIS YEAR AT ANOTHER FACILITY FOR BROKEN FEMUR. PATIENT TWISTED A COUPLE OF MONTHS LATER AND HEARD A LOUD CRACK AND FELT PAIN IN HER HIP. IM NAIL BROKEN PROXIMALLY, JUST SUPERIOR TO NAIL HOLE FOR LAG SCREW. PROXIMAL MOST DISTAL INTERLOCK SCREWS - PER MEDICAL NOTE."

  Patient problems: Pain

  MAUDE report 5105219 ↗