GAMMA 3425-1340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252273820), received between Jun 27, 2022 and Aug 4, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (7 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.

• InjuryAug 4, 2026Fracture

  As reported: "The patient reported having felt a stabbing pain after just under six weeks of successful and safe mobilisation. An X-ray revealed that the nail had broken, without any preceding fall."

  Patient problems: Pain

  MAUDE report 50132072 ↗
• InjuryJun 10, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA NAIL. THE NAIL HAS BEEN EXPLANTED."

  Patient problems: Failure of Implant

  MAUDE report 19499556 ↗
• InjuryJun 6, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "LONG GAMMA NAIL BROKE REQUIRING REVISION."

  Patient problems: Failure of Implant

  MAUDE report 19476927 ↗
• InjuryJul 24, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE IMPLANTATION TOOK PLACE ON (B)(6) 2022. SINCE ON (B)(6) 2023, THERE WAS INCREASING PAIN, THEN IN X-RAY ON (B)(6) 2023 THERE WAS EVIDENCE OF IMPLANT FRACTURE." THIS RESULTED IN A REVISION SURGERY.

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

  MAUDE report 17378158 ↗
• InjuryApr 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE NAIL. A REVISION WILL PROBABLY HAVE TO BE PERFORMED."

  Patient problems: Failure of Implant

  MAUDE report 16820689 ↗
• InjuryApr 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE NAIL. A REVISION WILL PROBABLY HAVE TO BE PERFORMED."

  Patient problems: Failure of Implant

  MAUDE report 16820688 ↗
• InjuryDec 16, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A GAMMA 3 SHS MIGRATED THREE MONTHS AFTER SURGERY, RESULTING IN A REVISION.

  Patient problems: Failure of Implant

  MAUDE report 16000409 ↗
• InjuryJun 27, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE "GAMMA NAIL 11X340" WITH 85 SHANK SCREW INSERTED ON (B)(6)2020. A REVISION SURGERY WAS PERFORMED."

  Patient problems: Failure of Implant

  MAUDE report 14830698 ↗