GAMMA 1320-1118Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154893652), received between Jul 18, 2019 and Oct 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SPEEDLOCK SLEEVE WAS FAULTY.

  Patient problems: Insufficient Information

  MAUDE report 17990028 ↗
• MalfunctionDec 5, 2020Failure to Align; Failure to Align

  AS REPORTED: "DOING CASE AND NOTICED TARGETING ARM WAS CRACKED AND SPEED SLEEVE DID NOT TARGET DISTAL SCREW PROPERLY. THE DRILL BIT WENT POSTERIOR. THE NAIL WAS ALREADY SEATED SO WE JUST USED A DIFFERENT SPEED SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10952141 ↗
• MalfunctionOct 1, 2019Material Fragmentation; Difficult to Remove; Mechanical Jam; Physical Resistance/Sticking; Material Fragmentation; Mechanical Jam

  AS REPORTED: "DURING AN INSERTION OF A LONG GAMMA NAIL, THE SURGEON NEEDED TO BACK OUT NAIL FOR CORRECT LAG SCREW POSITION. WHEN TRYING TO REMOVE NAIL HOLDING BOLT, SURGEON NOTICED BOLT WAS COMPROMISED. SURGEON STRUGGLED TO GET BOLT OFF TARGETER, SURGICAL TECH COULD NOT SEPARATE SLEEVE FROM TARGETER. SHE STATED TO ME IT WAS STUCK, SHE PULLED APART AND PLASTIC PIECES FLEW EVERYWHERE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9143473 ↗
• MalfunctionJul 18, 2019Failure to Align; Failure to Advance

  THE SPEED SLEEVE AND TARGETING ARM WOULD NOT ALLOW THE LAG SCREW SLEEVES TO PASS THROUGH TO LINE UP WITH THE PROXIMAL LAG SCREW HOLE IN THE NAIL. THE SPEED SLEEVE WAS REMOVED AND THE SURGEON DID WHAT HE COULD TO MAKE SURE HE HAD THE PROPER ALIGNMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804340 ↗