GAMMA 3330-0320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153313724), received between Mar 22, 2019 and Mar 22, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2019Break; Fracture; Fracture

  GAMMA3 LONG NAIL IMPLANTED AT THE (B)(6) ON (B)(6) 2018 - HAS RECENTLY BEEN REMOVED BECAUSE OF ITS BREAKAGE NEAR THE HOLE OF THE CEPHALIC SCREW. THIS NAIL WAS IMPLANTED WHEN THE PREVIOUS NAIL (NON-STRYKER) HAD BEEN REMOVED. SURGICAL REPORT: IN A POSTERIOR POSITION ON THE TRACTION BED A LATERAL INCISION OF THE HIP IS PERFORMED, PROLONGING THE PREVIOUS SCAR. THE BAND IS CUT, IDENTIFIED THE NAIL AND THE CEPHALIC SCREW. REMOVAL OF THE CAP, THE PROSALTED PORTION OF THE NAIL WHICH IS BROKEN AT THE LEVEL OF THE CEPHALIC SCREW HOLE. REMOVAL OF THE CEPHALIC SCREW, OF THE DISTAL PART OF THE NAIL. FRACTURE REDUCTION AND TEMPORARY SYNTHESIS WITH REDUCTION FORCEPS GUIDE WIRE IS POSITIONED AND THE FEMORAL CANAL IS RAISED. INTRODUCTION LONG NAIL 320 X 11 X 130. AMPOSCOPIC CONTROL, 95MM CEPHALIC SCREW. 2 METAL RIMS ARE APPLIED TO THE FEMORAL SHAFT WITH THE APPROPRIATE INSTRUMENTS POSITIONED 2 DISTAL STABILIZATION SCREWS. AMPLIOSCOPIC CONTROL THAT HIGHLIGHTS THE MIGRATION IN THE MEDIAL SOFT TISSUES OF THE CEPHALIC SCREW STABILIZATION SCREW. UNDER THE AMPLIOSCOPIC CONTROL, THE SCREW IS IDENTIFIED REMOVED. STABILIZATION SCREW POSITIONING AND PROXIMAL CAP. WASH. DRAINAGE. SUTURE. DRESSING.

  Patient problems: Failure of Implant

  MAUDE report 8445751 ↗