GAMMA 1320-0066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540487667), received between Nov 5, 2018 and Apr 5, 2023 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "A SHORT GAMMA3 NAIL WAS REMOVED TO IMPLANT A HIP PROSTHESIS. WHEN REMOVING THE END CAP, THE DISTAL SCREWDRIVER HEAD OF THE INSTRUMENT BROKE OFF. OUR LOANER KIT WAS USED FOR THE EXTRACTION. ANOTHER SET OF INSTRUMENTS HAD TO BE ORDERED FROM ANOTHER HOSPITAL, WHICH RESULTED IN A SURGICAL DELAY OF ALMOST 60 MINUTES." AJ (B)(6) 2023, REP CONFIRMED THAT THE NAIL WAS INTACT AND IT WAS ONLY REMOVED AS PATIENT REQUIRED FULL PROSTHESIS. KT (B)(6) 2023: REP CONFIRMED THAT THE REASON FOR THE CONVERSION WAS A HIP JOINT ARTHROSIS AND THAT THE SURGEON WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY AFTER GETTING AN ADDITIONAL INSTRUMENT KIT FROM ANOTHER HOSPITAL. REP FURTHER CONFIRMED THAT THE BROKEN TIP OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND THAT ALL (THREE) PARTS WERE ALREADY RETURNED TO THE MANUFACTURER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684056 ↗
• MalfunctionJul 30, 2019Fracture; Break; Fracture

  THE DRIVER WAS BROKEN DURING THE GAMMA 3 IMPLANT PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843777 ↗
• MalfunctionNov 5, 2018Break

  WHEN INSERTING THE END CAP, THE TIP OF THE SCREWDRIVER WAS DAMAGED AND REMAIN A BROKEN TIP BEHIND IN THE BODY. REMOVED THE DESTRUCTION AND COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039724 ↗