GAMMA 3066-0075SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540595959), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionFeb 20, 2019Difficult to Insert

  AFTER FIXED WITH A NESPONON CABLE, INSERTED THE LONG GAMMA NAIL WITH FEMORAL TROCHANTER FRACTURE LONG GAMMA NAIL RIGHT 125 ° 10 MM DIAMETER 300 MM LENGTH, BUT THE GUIDE PIN OF THE LAG SCREW INTERFERED WITH THE NAIL. SINCE THE STEP DRILL INTERFERES EVEN WHEN INSERTING THE GUIDE PIN OF THE LAG SCREW, IT REAMS WITH THE FLEXIBLE REAMER 8 MM AND INSERTS THE U LAG SCREW 75 MM. BECAUSE THE U BLADE FORCEDLY INSERTED THE LAG SCREW, IT DID NOT INSERT WELL AND DID NOT INSERT IT. TWO DISTAL LATERAL STOPS INSERTED IN FREEHAND. AFTER CHECKING WITH THE X - RAY AFTER SURGERY, THE LAG SCREW DID NOT GO THROUGH THE NAIL HOLE AND INSERTED IN FRONT OF THE NAIL. SINCE THE PATIENT WAS 91 YEARS OLD, SO REMAIN TO OBSERVATION. THE LAG SCREW DID NOT GO THROUGH THE NAIL HOLE AND INSERTED IN FRONT OF THE NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356277 ↗