GALILEO® LOCKING TOOL 5031-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848665031522), received between May 22, 2024 and May 11, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  ON 22-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 5031-000 GALILEO TOOL IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135366 ↗
• MalfunctionMay 14, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: DURING A TROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE, THE COMPRESSION WHEEL AND INSERTER HANDLE FAILED TO PROVIDE PROPER COMPRESSION, EXHIBITING SLIPPING OR CLICKING AT A CERTAIN POINT WHEN ATTEMPTING TO COMPRESS. THIS ISSUE HAD PREVIOUSLY BEEN OBSERVED IN THREE CASES INVOLVING TROCH NAILS, THOUGH SPECIFIC DATES OR CASE DETAILS ARE UNAVAILABLE. WHILE THE ISSUE DID NOT IMPACT THE CASES OR PATIENTS, A RECURRING PATTERN WAS LATER IDENTIFIED. THE CASE WAS COMPLETED IN STANDARD FASHION, ACHIEVING AS MUCH COMPRESSION AS THE INSTRUMENT ALLOWED WITHOUT REQUIRING ADDITIONAL PRODUCTS. THERE WAS NO REPORTED DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AFFECTED PRODUCTS, IN THIS CASE, INCLUDED THE LAG SCREW INSERTER AND COMPRESSION WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017957 ↗
• MalfunctionMay 14, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: DURING A TROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE, THE COMPRESSION WHEEL AND INSERTER HANDLE FAILED TO PROVIDE PROPER COMPRESSION, EXHIBITING SLIPPING OR CLICKING AT A CERTAIN POINT WHEN ATTEMPTING TO COMPRESS. THIS ISSUE HAD PREVIOUSLY BEEN OBSERVED IN THREE CASES INVOLVING TROCH NAILS, THOUGH SPECIFIC DATES OR CASE DETAILS ARE UNAVAILABLE. WHILE THE ISSUE DID NOT IMPACT THE CASES OR PATIENTS, A RECURRING PATTERN WAS LATER IDENTIFIED. THE CASE WAS COMPLETED IN STANDARD FASHION, ACHIEVING AS MUCH COMPRESSION AS THE INSTRUMENT ALLOWED WITHOUT REQUIRING ADDITIONAL PRODUCTS. THERE WAS NO REPORTED DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AFFECTED PRODUCTS, IN THIS CASE, INCLUDED THE LAG SCREW INSERTER AND COMPRESSION WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017947 ↗
• MalfunctionJan 6, 2025Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON 01/16/2025: THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE ON (B)(6) 2024. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085199 ↗
• MalfunctionJan 3, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 12/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 5031-000 LOCKING TOOL AND 5030-000 LAG INSERTER WERE NOT ABLE TO WORK TOGETHER IN UNISON. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066923 ↗
• MalfunctionOct 16, 2024Positioning Failure; Positioning Failure

  ON 10/07/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5030-000 GALILEO LAG SCREW AND A 5031-000 GALILEO LOCKING TOOL DISENGAGED WHEN COMPRESSION WAS APPLIED RESULTING IN THE INSTRUMENTS NOT LOCKING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461895 ↗
• MalfunctionMay 24, 2024Unintended Movement; Unintended Movement

  ON 04/08/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A 5031-000 LOCKING TOOL IS NOT LOCKING. THIS OCCURRED DURING THE LAST 2 TROCH NAIL CASES WHEN THE BLACK T-HANDLE SEEMED TO BE ¿JUMPING¿ WHEN WE WOULD GO TO LOCK THE LAG SCREW INTO THE NAIL. IT WAS A CLEAR DIFFERENCE FROM THE ACTUAL TORQUE LIMITER ENGAGING. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392146 ↗
• MalfunctionMay 22, 2024Unintended Movement; Unintended Movement

  ON 12/30/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A 5 031-100 LAG SCREW LOCKING TOOL MAY HAVE BEEN IN QUESTION FOR RELIABILITY AND PERFORMANCE OF THE TORQUE LIMITER WHEN IT WAS USED TO LOCK A 1099-095 TELESCOPING LAG SCREW. THIS WAS DISCOVERED POST-OPERATIVE OF A TROCHANTERIC FEMORAL NAIL PROCEDURE THAT WAS PERFORMED ON (B)(6)2021. WHEN THE SURGEON X-RAYED THE PATIENT, IT WAS NOTICES THAT THE TELESCOPING LAG SCREW DID NOT STAY LOCKED UP. PRIOR TO THIS, THE TROCHANTERIC FEMORAL NAIL PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH NO ISSUES, NO BROKEN IMPLANTS AND OR INSTRUMENTS. AT THIS TIME THERE HAS BEEN NO REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375823 ↗