GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 90mm 1192-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848665036534), received between Aug 10, 2022 and Feb 3, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionFeb 3, 2025Failure to Advance; Failure to Advance

  ON 01/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFT LAG SCREW WOULD NOT ADVANCE THROUGH THE NAIL AND WAS SPINNING INSTEAD. THE SURGEON TRIED MULTIPLE TIMES TO REDRILL AND REINSERT THE SCREW WITHOUT SUCCESS AND DEEMED IT NOT FUNCTIONAL. NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON PROCEEDED TO IMPLANT A STANDARD RIGHT-THREADED LAG SCREW WHICH WAS IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 1/20/2025: THE CASE WAS COMPLETED USING A 1099-090 TELESCOPING LAG SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293645 ↗
• MalfunctionAug 21, 2024Device Dislodged or Dislocated; Damaged Thread; Device Dislodged or Dislocated; Damaged Thread

  ON 07/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFTY TELESCOPING LAG SCREW UNTHREADED INSIDE THE PATIENT. THE THREADS BROKE, AND THE SCREW WAS LEFT IMPLANTED. THIS WAS DISCOVERED DURING A HIP NAIL PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20017672 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 6/1/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A LOCKING NUT ON THE SCREW CAPTURING ROD SNAPPED OFF. WHILE TRYING TO REMOVE THE SCREW, THE LOCKING MECHANISM WAS DAMAGED. THIS WAS DISCOVERED DURING A HIP FRACTURE REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 6/2/2022 OVER THE PHONE: THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE AND NOTHING BROKE INSIDE THE PATIENT. ANOTHER TRAY WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19460563 ↗
• InjuryAug 18, 2022Device Dislodged or Dislocated

  IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN 1192-090 LAG SCREW BACKED OUT. THIS WAS DISCOVERED DURING AFTER THE SCREW WAS IMPLANTED FOR AN UNSPECIFIED TIME, A REVISION SURGERY IS PLANNED. REVISION DATE (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15250098 ↗
• MalfunctionAug 10, 2022Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-090 LEFTY TIGHT LAG SCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. WHEN THE SURGEON ATTEMPTED TO ADVANCE THE SCREW, IT BROKE INSIDE THE PATIENT. THE SCREW WAS RETRIEVED AND WAS REPLACED WITH AN 1099-090 GALILEO LAG SCREW.

  Patient problems: Insufficient Information

  MAUDE report 15200736 ↗