GAMMA 1320-0234Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154978069), received between Feb 13, 2020 and Mar 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMar 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  AS REPORTED: "WHILE TIGHTENING THE GAMMA4 GRUB SCREW, THE WIRE ON THE FLEXIBLE SCREWDRIVER CAME LOOSE. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710599 ↗
• MalfunctionFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AT THE END OF A LONG GAMMA NAIL CASE, THE SURGEON TIED A SUTURE ON THE SET SCREW (FINAL SCREW) DUE TO A CONCERN THAT THE SCREW MIGHT GET LOST IN THE PATIENT. WHEN TIGHTENING THE SCREW, THE SUTURE WRAPPED AROUND THE SET SCREW SCREWDRIVER. THE ENTIRE BLUE SHEATH OF THE SCREWDRIVER CAME OFF INTO THE NAIL. THE SURGEON BEGAN ATTEMPTING TO TAKE THE NAIL OUT, BUT DECIDED AGAINST DOING SO AND COMPLETED THE CASE WITH THE BLUE PLASTIC SHEATH STILL IN THE NAIL. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9709873 ↗