GAMMA 1320-0011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540388940), received between Jul 8, 2019 and Mar 4, 2020 — classified as 2 malfunctions.

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 18, 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 4, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT FEMUR. IT WAS REPORTED THAT THE 15 +5 OPENING REAMER SNAPPED AT THE TAPER FOR CHUCKING INTO THE DRILL. THE DEVICE HAD NOT YET COME IN CONTACT WITH PATIENT BONE, BUT WAS IN THE SOFT TISSUE. THE LOCATION OF THE BREAK WAS OUTSIDE OF THE PATIENT. THE DEVICE WAS REMOVED, PATIENT VISUALLY INSPECTED, AND DEVICE REASSEMBLED AT BACK TABLE TO ENSURE NO PIECES REMAINED IN THE PATIENT. A SECOND INSTRUMENT WAS OBTAINED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF LESS THAN ONE MINUTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789626 ↗
• MalfunctionJul 8, 2019Break

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT FEMUR WITH A GAMMA NAIL, THE 1-STEP REAMER BROKE WHERE IT ATTACHES TO THE DRILL. ANOTHER INSTRUMENT SET WAS AVAILABLE IN THE OPERATING ROOM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767254 ↗