GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 100mm 1192-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665036558), received between Jun 7, 2024 and Oct 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 9/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTY LAG SCREW GOT STUCK TOGETHER AND COULD NOT BE TAKEN APART. THIS WAS DISCOVERED DURING A TROCH NAIL PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A NEW 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTLY LAG SCREW. ADDITIONAL INFORMATION RECEIVED ON 9/27/2024: IT WAS NOTICED AFTER THE SURGERY THAT THE 0857-100 CAPTURING ROD AND 1192-100 LEFTY TIGHTY LAG SCREW GOT STUCK TOGETHER. ADDITIONAL INFORMATION RECEIVED ON 10/4/2024: THIS OCCURRED DURING A REVISION SURGERY. THE SCREW HAD COLLAPSED ALL THE WAY AND ENDED UP CUTTING THROUGH THE HEAD. ALL PRODUCTS WERE REMOVED, AND THE CASE WAS COMPLETED AS A TOTAL HIP PROCEDURE. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2024. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 20463005 ↗
• MalfunctionJun 7, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-100 TELESCOPING LAG SCREW, A 1099-110 TELESCOPING LAG SCREW, AND A 1099-100 TELESCOPING LAG SCREW WOULD NOT ADVANCE INTO THE FEMORAL HEAD OF AN AR-9094-10-2030 TROCHANTERIC NAIL. THE TELESCOPING LAG SCREWS WERE USED WITH A NEW TROCHANTERIC NAIL; HOWEVER, THE ISSUE PERSISTED, AND THE TELESCOPING LAG SCREWS WOULD STILL NOT ADVANCE. THE CASE WAS COMPLETED USING A NEW TROCHANTERIC NAIL AND A NEW 1099-110 TELESCOPING LAG SCREW. THE CASE WAS DELAYED ABOUT FIFTEEN MINUTES. THIS WAS DISCOVERED DURING A LEFT HIP IM NAIL PROCEDURE ON (B)(6) 2024.

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

  MAUDE report 19487379 ↗