GAMMA 3230-0400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153313069), received between Jun 7, 2019 and Nov 6, 2020 — 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.

• InjuryNov 6, 2020Fracture; Separation Problem; Fracture; Separation Problem

  A PHARMACIST STUDENT REPORTED THAT : "PROTRUDING GAMMA NAIL IN CONFLICT WITH THE GLUTEUS MEDIUS. NON-COMPLETE REMOVAL OF THE NAIL. DIAPHYSEAL PART LEFT IN PLACE."

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 10805543 ↗
• InjuryJun 7, 2019Fracture

  PATIENT HAD SLIPPED SEVERAL TIMES FROM A BICYCLE PEDALS AND CAME HARD WITH THE AFFECTED LIMB - THEN THE APPEARANCE OR STRAINING WAS NO LONGER POSSIBLE. RADIOLOGICALLY SECURED NAIL FRACTURE PROXIMAL TO THE FEMORAL NECK SCREW WITH THE ABOVE MENTIONED PRODUCT MENTIONED ABOVE. INTRAOPERATIVE RECOVERY OF THE IMPLANT WILL TAKE PLACE.

  Patient problems: Fall

  MAUDE report 8680823 ↗