GAMMA 1320-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540377869), received between Aug 19, 2015 and Nov 16, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2020Fracture; Fracture

  AS REPORTED: "DURING THE GAMMA U LAG OPERATION, WHEN THE SURGEON TRIED TO INSERT THE U BLADE WITH THE INSERTER ACCORDING TO THE NORMAL PROCEDURE, 13200330 (U LUG SCREW CONNECTOR) WAS DAMAGED AND BROKE. IT WAS SUCCESSFULLY REMOVED WITH THE PLIERS AT THE HOSPITAL. DAMAGE DUE TO METAL FATIGUE WAS SUSPECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10843650 ↗
• MalfunctionMay 17, 2019Break

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, SURGEON IMPLANTED A SHORT GAMMA NAIL, RC LAG SCREW, AND DISTAL LOCKING SCREW. DURING INSERTION OF THE RC LAG SCREW OP TECH PROTOCOL WAS FOLLOWED. THE U BLADE LAG SCREW CONNECTOR BROKE AFTER THE U BLADE INSERTER WAS PLACED OVER IT AND THE HANDLE WAS PRESSED 3-4 TIMES. PATIENT WAS NOT HARMED AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621427 ↗
• MalfunctionNov 19, 2018Break

  INSERT GAMMA NAIL AND INSERT U LAG SCREW. CONNECTING U LAG SCREW CONNECTOR TO THE END OF THE LAG SCREW, INSERTING THE U BLADE AND PUSHING IT IN 3 TIMES WITH THE U INSERTER, THE U LAG SCREW CONNECTOR BREAKS AT THE MIDDLE GROOVE. INSERTION OF THE U BLADE GAVE UP AND CONTINUED WITH THE LAG SCREW INSERTED, AND IT ENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084096 ↗
• MalfunctionOct 1, 2018Break

  DURING GAMMA3 SURGERY, U-BLADE LAG SCREW CONNECTOR WAS BROKEN IN TWO AT BLACK MARKER PORTION WHEN INSERTING A U-BLADE USING U-BLADE INSERTER. THE BROKEN CONNECTOR WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7923905 ↗
• MalfunctionAug 19, 2015Break

  IT WAS REPORTED THAT DURING G3 NAIL SURGERY, THE SURGEON TRIED TO INSERT THE U-BLADE. HOWEVER, THE U-BLADE INSERTION WAS DIFFICULT. WHEN THE SURGEON TRIED TO INSERT U-BLADE FORCIBLY USING AN INSERTER, CONNECTOR BROKE. THEREFORE THE SURGEON DID NOT INSERTED U-BLADE. AND THE SURGERY WAS FINISHED. ADDITIONAL INFORMATION: THERE IS A POSSIBILITY THAT AN END OF LAG SCREW WAS INSERTED MORE DEEPLY THAN A LATERAL CORTICAL BONE. THEREFORE THE SURGEON COULD NOT INSERT U-BLADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5016144 ↗