GAMMA 3425-0260SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540375308), received between Sep 4, 2015 and Oct 10, 2025 — classified as 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2025Fracture; Fracture

  AS REPORTED: "A PATIENT WHO UNDERWENT SURGERY ON (B)(6) 2025, VISITED THE HOSPITAL ON (B)(6) 2025 COMPLAINING OF PAIN. AN X-RAY REVEALED A BROKEN NAIL. THE BROKEN AREA WAS NEAR THE LAG SCREW HOLE.".

  Patient problems: Pain

  MAUDE report 23265547 ↗
• InjuryAug 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE NAIL BROKE WHICH RESULTED IN BHA REVISION SURGERY. THE NAIL BREAKAGE WAS NOTICED DUE TO PAIN APPEARING WITHOUT TRAUMATIC FACTORS AND IT WAS NOTICED THAT THERE WAS A DELAYED UNION.

  Patient problems: Failure of Implant; Impaired Healing; Implant Pain

  MAUDE report 15240186 ↗
• InjuryFeb 22, 2022Break; Break

  AS REPORTED: "THE FALL RESULTED IN A NEW FRACTURE AT THE DISTAL END OF THE NAIL AND SUBTROCHANTERIC RE-FRACTURE AND NAIL DEFORMITY. REVISION SURGERY IS SCHEDULED ON JANUARY 28 OR 29."

  Patient problems: Failure of Implant; Fall; Limb Fracture

  MAUDE report 13577965 ↗
• InjuryOct 20, 2020Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPERATION FOR FRACTURE OF THE PROXIMAL FEMUR. ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO BREAKAGE OF THE IMPLANT. IT IS UNCERTAIN WHEN THE IMPLANT BROKE." THE ADDITIONAL INFORMATION WAS RECEIVED: "TROCHANTERIC FRACTURE REVERSE TYPE (REVERSE OBLIQUE FRACTURE UNDER LUG SCREW)NAIL WAS USED IN THE OPERATION OF THE SECOND REVISION, AND THE PROGRESS IS GOOD. A GAP REMAINED IN THE FRACTURED PART IN A DIFFICULT REDUCTION CASE IT IS BELIEVED THAT THE IMPLANT IS LIKELY TO HAVE BROKEN [...]." THE ADDITIONAL INFORMATION ON PATIENT'S HISTORY WAS RECEIVED: "THE PATIENT HAD HISTORY OF LEFT THA, LUMBAR COMPRESSION FRACTURE (CONSERVATIVE THERAPY)."

  Patient problems: Failure of Implant

  MAUDE report 10708428 ↗
• MalfunctionApr 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AS REPORTED: "THE IMPLANTING PROCEDURE WAS [PERFORMED] FOR THE LEFT FEMUR, BUT THE RIGHT IMPLANT WAS IMPLANTED. SR NOTICED MISS IMPLANTING THE RIGHT NAIL FOR LEFT FEMUR AFTER PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9924838 ↗
• InjuryMar 5, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018 A LONG GAMMA NAIL WAS IMPLANTED. DURING FOLLOW UP 2 WEEKS AFTER SURGERY, AND THERE WAS NO PROBLEM. HOWEVER DUE TO FALL OVER ON (B)(6) 2019, PATIENT WAS COMPLAINING OF PAIN. DURING REVISION SURGERY ON (B)(6) 2018 CUT OUT THE SCREW WAS DISCOVERED.

  Patient problems: Pain

  MAUDE report 8392758 ↗
• InjuryNov 29, 2017Fracture; Improper or Incorrect Procedure or Method

  THE PHYSICIAN ACCIDENTALLY DEPLOYED THE RIGHT LONG GAMMA NAIL ON THE LEFT. ALTHOUGH IT FIXED AS IT WAS, RECURRENT FRACTURE WAS CONFIRMED AT AFTER OPERATION XP AND THE NAIL WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7069103 ↗
• InjurySep 4, 2015Break

  IT WAS REPORTED THAT ON (B)(6) 2015, GAMMA3 LONG NAIL SURGERY WAS PERFORMED. SEVEN MONTHS AFTER THE SURGERY, BREAKAGE OF THE NAIL WAS FOUND AND REVISION SURGERY TO BIPOLAR WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 5055710 ↗