GAMMA 1420-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327510133), received between Oct 27, 2025 and Jun 18, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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.

• InjuryJun 18, 2026Failure to Align

  THE SALES REP REPORTED THAT WHEN IN USE, THE REAMER OSCILLATES ABNORMALLY. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS COMPLETED, BUT THE OPERATING TIME WAS EXTENDED. THIS HAD AN IMPACT ON THE PATIENT, AS THE DRILL BIT RUBBED AGAINST THE NAIL, CAUSING TITANIUM DEBRIS TO ENTER THE PATIENT¿S BODY. TWO MOTORS WERE USED TO VERIFY THAT THE PROBLEM WAS NOT WITH THE DRILL CHUCK, BUT THE ISSUE PERSISTED. FOR THE PATIENT, THERE WAS AN INCREASED RISK OF INFECTION DUE TO THE LONGER PROCEDURE TIME AND MORE FREQUENT ENTRIES AND EXITS FROM THE OPERATING ROOM. INCREASED STERILIZATION VOLUME, LONGER OPERATING ROOM OCCUPANCY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25548587 ↗
• MalfunctionMar 23, 2026Material Fragmentation; Failure to Align

  AS REPORTED: "WHEN USING THE LAG SCREW DRILL, THERE WAS SLIGHT RESISTANCE, AND WHEN REMOVING THE DRILL BIT, A METAL-LIKE FRAGMENT WAS ADHERING TO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661194 ↗
• MalfunctionOct 27, 2025Failure to Align; Failure to Align

  AS REPORTED: "CUSTOMER WAS NOT ABLE TO HIT THE NAIL CORRECTLY WITH THE FEMORAL NECK SCREW DRILL. THE NAIL WAS HIT WITH THE DRILL, THIS ALSO HAPPENED WITH THE SECOND NAIL. THE NAIL HOLDING SCREWS SHOW SIGNS OF WEAR." ADDITIONAL INFORMATION: ANOTHER NAIL WAS IMPLANTED AFTER THE FIRST NAIL WAS REMOVED. THE RESULT WITH THE SECOND NAIL WAS GOOD; THE DRILLED NAIL WAS NOT LEFT IN SITU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389611 ↗