GAMMA 3425-0300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540375322), received between Nov 10, 2021 and Jan 5, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

• InjuryJan 5, 2026Off-Label Use

  AS REPORTED: "BOTH SIDE NAILS (RIGHT AND LEFT) WERE PREPARED. A NAIL OPENED ON THE WRONG SIDE BY THE NURSE, BUT THE PHYSICIAN WAS NOT AWARE OF THIS PRIOR TO USE AND ONLY REALISED DURING THE PROCEDURE. AS A RESULT OF INSERTING THE NAIL AS IS, A FRACTURE OCCURRED ON THE FRONT OUTER SIDE DUE TO COLLISION AT THE NAIL TIP. AFTER INSERTING THE CORRECT NAIL, TWO CCS PINS WERE FIXED AND THEN WRAPPED THE WIRE."

  Patient problems: Bone Fracture(s)

  MAUDE report 23968280 ↗
• InjurySep 27, 2022Break; Fracture; Break; Fracture

  A PATIENT WAS ADMITTED TO (B)(6) MEDICAL AND (B)(6) HOSPITAL. A GAMMA 3 LONG NAIL IN THE PATIENT'S BODY WAS FOUND TO BE BROKEN. ON (B)(6) 2022 THE PATIENT WAS REVISED TO REMOVE THE BROKEN NAIL. THE IMPLANT WAS INSERTED AT (B)(6) HOSPITAL IN (B)(6) 2021- THE DATE OF THE INITIAL SURGERY IS UNSPECIFIED, BUT IS ESTIMATED TO BE ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 15493443 ↗
• InjuryMar 15, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2021, GAMMA 3 LONG NAIL WAS IMPLANTED FOR FEMORAL TROCHANTERIC FRACTURE DUE TO BONE TUMOR. IN FEBRUARY 2022, WITHOUT A FALL, THE PATIENT FELT PAIN DURING DAILY ACTIVITIES AND THE X-RAYS REVEALED NAIL FRACTURE. DURING REVISION, THE BROKEN NAIL WAS REMOVED AND GMRS WAS USED."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 13770790 ↗
• InjuryNov 10, 2021Fracture; Fracture

  AS REPORTED; "DAMAGE TO GAMMA NAILS IN THE BODY. INSERTED ABOUT HALF A YEAR AGO. THE DOCTOR'S VIEW WAS THAT IT WAS A VERY COMPLICATED FRACTURE AND THAT IT WAS DAMAGED BECAUSE THE PATIENT WAS YOUNG AND VERY ACTIVE." THE PATIENT REQUIRED AN IMPLANT EXPLANTATION TO REMOVE THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12785449 ↗