GAMMA 3525-1240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252274223), received between Oct 7, 2021 and Sep 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA3 NAIL. NAIL EXPLANTATION ON (B)(6) 2024 AFTER NAIL FRACTURE AND IMPLANTATION OF A NEW NAIL. THE PATIENT EXPERIENCED A FALL ON THE DAY OF NAIL BREAKAGE. CAUSE UNCLEAR."

  Patient problems: Failure of Implant; Fall

  MAUDE report 20226155 ↗
• InjuryOct 7, 2021Fracture; Fracture

  THE CUSTOMER REPORTS A SURGICAL TREATMENT OF A SUBTROCHANTERIC FEMUR FRACTURE ON THE LEFT USING A GAMMA 3 NAIL ON (B)(6) 2021. AFTER INITIALLY PROBLEM-FREE MOBILIZATION, INCREASING PAIN OCCURRED. A CT OF THE LEFT HIP PERFORMED ON (B)(6) 2021 SHOWS A NAIL FRACTURE AT A TYPICAL LOCATION AT THE PENETRATION POINT OF THE FEMORAL NECK SCREW WITH DELAYED CONSOLIDATION WITH VARUS DISLOCATION. REVISION SURGERY WAS PERFORMED.

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

  MAUDE report 12590066 ↗