GAMMA 3330-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153313748), received between Sep 17, 2019 and Sep 23, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 23, 2022Break; Fracture; Break; Fracture

  IN THE CONTEXT OF THE IMPLANTATION OF A GAMMANAGEL LONG NAIL GAMMA3 R2.0, TI, 11X340 MM/130° LEFT (3330-0340) CE 0123K042A3A, WE HAVE RECEIVED A LAWYER'S LETTER. ACCORDING TO THIS LETTER, THE GAMMA NAIL, WHICH WAS IMPLANTED ON (B)(6) 2022, BROKE ONLY A FEW WEEKS LATER AND WAS REPLACED ON (B)(6) 2022. THE PATIENT WAS IMPLANTED WITH A NEW GAMMA NAIL WITH A LENGTH OF 360 MM AS PART OF THE REVISION SURGERY. THE PATIENT IS NOT ALLOWED TO BEAR WEIGHT UNTIL (B)(6) 2022 AND WAS SET BACK OVERALL IN HER RECOVERY PROCESS. MOBILIZATION WILL BE SIGNIFICANTLY MORE COMPLEX.

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

  MAUDE report 15470189 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT WAS HIT BY A CAR ON (B)(6) 2017 SUSTAINING A LEFT FEMORAL FRACTURE. (B)(6) 2018 THE FRACTURE WAS ADDRESSED BY IMPLANTATION OF A GAMMA3 LONG NAIL AND LAG SCREW. PATIENT HAS SINCE ALLEGED PAIN.

  Patient problems: Pain

  MAUDE report 9079594 ↗