GAMMA 1320-0070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540377647), received between Feb 27, 2020 and Nov 22, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Break; Fracture; Device Difficult to Setup or Prepare; Break; Fracture; Device Difficult to Setup or Prepare

  DURING INSERTION OF THE LOCKING SCREW OF GAMMA 3, THE TORQUE BECAME HARD, AND THE LOCKING SCREW WAS INSERTED USING PLIERS ON THE HANDLE PART OF THE SCREWDRIVER. THE HANDLE OF THE SCREWDRIVER WAS DAMAGED IN THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757488 ↗
• MalfunctionJul 9, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  NAIL HOLDING SCREW DID NOT LOOSEN WITH NORMAL FORCE. EVENTUALLY, THE DEVICE WAS REMOVED, BUT DAMAGE OF THE NAIL HOLDING SCREW AND STRIKE PLATE WAS OBSERVED. DAMAGED MATERIAL THAT COULD BE SEEN IN THE X-RAY WAS REMOVED FROM PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704706 ↗
• MalfunctionSep 16, 2020Fracture; Fracture

  AS REPORTED: "WHEN OPERATING A LONG GAMMA NAIL, INSERT A NAIL 3 SCREW DRIVER STRIKE PLATE (13200070) INTO THE DEVICE WHEN INSERTING THE NAIL INTO THE MEDULLARY CAVITY AND HIT IT WITH A HAMMER. THE OPERATION PROCEEDED WITHOUT PROBLEMS AND ENTERED A CLOSED WOUND, BUT A METAL PIECE LIKE A NEEDLE POINT WAS FOUND ON THE OPERATION TABLE. CHECK IF THERE ARE ANY METAL PIECES IN THE BODY WITH C-ARM, ETC. SINCE NO SUCH METAL PIECES WERE FOUND, CAREFULLY WASH AND CLOSE THE WOUND. WHEN THE INSTRUMENT WAS INSPECTED AFTER AN X-RAY, IT WAS FOUND THAT THE RECESS ON THE TIP OF THE HAMMER 3 SCREW DRIVER STRIKE PLATE (13200070) AND THE METAL PIECE SUCH AS THE NEEDLE POINT WERE ALIGNED. PROBABLY THE CAUSE WAS HITTING WITH A HAMMER 3 SCREW DRIVER STRIKE PLATE (13200070) APPLIED TO THE UNIVERSAL ROD CONNECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10542439 ↗
• MalfunctionFeb 27, 2020Break; Break

  THE SNAP RING ON THE THREAD IS BROKEN. THE SCREWDRIVER CAN NO LONGER BE SCREWED IN. THE BREAKAGE WAS OBSERVED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766460 ↗