GAMMA 8425-2320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327476415), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 18, 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.

• MalfunctionAug 20, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "AFTER PERFORMING A CALIBRATION CHECK AND INSERTING THE GAMMA LONG NAIL ACCORDING TO THE MANUAL, THE LAG SCREW WAS INSERTED. WHEN ATTEMPTING TO ATTACH THE U-GUIDE TO THE LAG SCREW, IT COULD NOT BE ATTACHED. THE SURGEONS CONFIRMED WITH X-RAYS THAT THE LAG SCREW ITSELF HAD SLIPPED OUT OF THE LAG SCREW HOLE AND WAS INSERTED THROUGH THE FRONT OF THE NAIL. (AFTER INSERTING THE NAIL, THE NAIL WAS RETIGHTENED WITH A BALL-TIP SCREWDRIVER, AND A CALIBRATION CHECK WAS ALSO PERFORMED BEFORE INSERTION. ALL PROCEDURES WERE PERFORMED ACCORDING TO THE MANUAL, AND THE PRECISION PIN WAS ALSO INSERTED IN THE CORRECT ORDER THROUGH THE SLEEVE BEFORE PERFORMING THE LAG SCREW DRILL.) THE LAG SCREW THAT COULD NOT BE INSERTED IN THE CORRECT POSITION WAS REMOVED. AFTER SLIGHTLY DEEPENING THE NAIL, THE PRECISION PIN WAS REINSERTED, AND IT ENTERED WHILE INTERFERING WITH THE LAG SCREW HOLE OF THE NAIL. THE LAG SCREW DRILL WAS ALSO RE-DRILLED WHILE INTERFERING WITH THE LAG SCREW HOLE. AFTER THAT, THE REMOVED LAG SCREW WAS REINSERTED, AND THE OPERATION WAS COMPLETED. ALTHOUGH THE CONNECTION IS UNCLEAR, WHEN THE PRECISION PIN WAS FIRST INSERTED AND DRILLING WAS PERFORMED, THERE WAS A BONE FRAGMENT P

  Patient problems: Insufficient Information

  MAUDE report 22848762 ↗