GALILEO® LAG SCREW INSERTER 5030-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00848665036244), received between Feb 7, 2022 and Jan 9, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06733992 THAT A 5033-100 GALILEO® CAPTURING ROD AND AN 5046-100 GALILEO® CAPTURING ROD NUT WILL NOT UNSCREW AND ARE STUCK IN THE 5030-000 GALILEO® LAG SCREW INSERTER. A BACKUP SET WAS AVAILABLE, AND THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113701 ↗
• MalfunctionJan 6, 2025Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 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 21085194 ↗
• MalfunctionJan 3, 2025Use of Device Problem; Use of Device Problem

  ON 12/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) 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 21067518 ↗
• MalfunctionOct 22, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06680482 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 20508704 ↗
• MalfunctionJun 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON 05/12/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN 5030-000 SCREW INSERTER FELL APART. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "WHEN TAKING OUT THE LAG SCREW INSERTER DEVICE FROM THE STERILIZED TRAY, THE SCREW/PIN THAT HOLDS THE SPRING LOADED GOLD MECHANISM TO SHIFT BETWEEN SCREWDRIVER/ACTIVATING THE LAG SCREW LOCK MECHANISM LAUNCHED FROM ITS POSITION INTO THE AIR. NOTHING WAS DONE TO CREATE THIS ACTION. WE WERE ABLE TO LOCATE THE SCREW/PIN AND ABLE TO REINSERT IT (ALBEIT LOOSELY) INTO THE LAG SCREW INSERTER DEVICE. WE PROCEEDED TO COMPLETE THE CASE WITHOUT ISSUE, ALTHOUGH IT WAS CLEAR BASED ON THE BLUE/BLACK VISUALS YOU SEE TO GUIDE THE DEVICE THAT THERE WAS SOMETHING WRONG. UPON DISASSEMBLING THE LAG SCREW DRIVER, THE SCREW/PIN LAUNCHED INTO THE AIR AND WE WERE NOT ABLE TO FIND IT ON THE OR FLOOR. IT IS AN INCREDIBLY SMALL PIECE THAT HOLDS THE CONSTRUCT TOGETHER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570059 ↗
• MalfunctionJun 19, 2024Break; Break

  ON 10/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5030-000 LAG SCREW INSERTER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19569446 ↗
• MalfunctionJun 19, 2024Break; Break

  ON 01/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT SEVERAL INSTRUMENTS WERE BROKEN/ NOT WORKING CORRECTLY THE 0312-200 LAG SCREW TRIPLE SHEATH OBTURATOR( LINE#1) BLACK RELEASE BUTTON WOULD NOT DISENGAGE, THE 5030-000 LAG SCREW INSERTER (LINE#2) GOLD RELEASE MECHANISM BROKE THE PIN IS MISSING THAT KEEPS IT TOGETHER, AND THE 0616-000 LAG SCREW (LINE#3) OBTURATOR BLACK KNOB AT THE END POPPED OFF WHILE GETTING THE TRIPLE SHEATH DOWN TO BONE. THIS WAS DISCOVERED DURING USE IN A TROCH NAIL ON (B)(6) 2022. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568883 ↗
• MalfunctionJun 19, 2024Component Missing; Component Missing

  ON 05/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 5030-000 LAG SCREW INSERTER SEEMS TO BE MISSING A PIN TO HOLD THE SPRING IN PLACE. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568601 ↗
• MalfunctionJun 19, 2024Break; Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 5030-000 GALILEO® LAG SCREW INSERTER HAD AN ISSUE. WHILE DOING AN IN-SERVICE ON (B)(6) 2022, A SMALL PIECE POPPED OFF AND THE HANDLE IS NOW BROKEN. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567901 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED ON 04/13/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN 5030-000 LAG SCREW INSERTER BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567199 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED ON 09/14/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT A 5030-000 LAG SCREW INSERTER BROKE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566638 ↗
• MalfunctionJun 19, 2024Material Separation; Material Separation

  ON 5/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5030-000 LAG SCREW INSERTER PIN POPPED OUT DURING THE PROCEDURE, NOT ALLOWING THE SURGEON TO PROPERLY ENGAGE THE LAG SCREW LOCKING TOOL. UPON REMOVAL O THE 1192-120 LAG SCREW, IT WAS DETERMINED THAT IT WAS MISSING THE LOCKING RING. SURGEON MADE SURE IT HAD NOT BROKEN INSIDE THE PATIENT AND CONFIRMED IT DID NOT; THEREFORE DETERMINED IT WAS MISSING UPON OPENING PACKAGE. A SECOND LAG SCREW WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN INTERTROCHANTERIC FRACTURE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566162 ↗
• MalfunctionJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON 08/19/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 5030-000 GALILEO SCREW RETAINING PIN FELL OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518713 ↗
• MalfunctionMay 22, 2024Break; Break

  ON 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A 5030-000 GALILEO LAG SCREW INSERTERS GOLD RELEASE MECHANISM BROKE. THIS OCCURRED DURING A CASE WHEN A METAL PIECE APPEARED ON THE X-RAY, AND THEY COULD NOT ADVANCE THE SCREW ANY FURTHER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19378372 ↗
• InjuryMay 23, 2023Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 5030-000 LAG SCREW INSERTER WOULD NOT LOCK ONTO LAG SCREW, AND AN 5033-100 CAPTURING ROD WAS BROKEN. THIS WAS DISCOVERED DURING AND AFTER A CASE, PROCEDURE WAS DELAYED AND PATIENT WAS KEPT UNDER ADDITIONAL ANESTHESIA. PER FACILITY: "LAG SCREW INSERTER WOULD NOT RELIABLY CAPTURE AND COMPLETELY SEAT ANY OF THE LAG SCREWS. THIS RESULTED IN DIFFICULTY INSERTING THE SCREW AND POTENTIALLY LED TO ISSUES LOCKING THE SCREW INTO THE NAIL. UPON INSPECTION FOLLOWING THE CASE, THE LAG SCREW CAPTURING ROD WAS ALSO BROKEN. EVEN PUTTING THE CAPTURING ROD ASIDE, THE INSERTER CLEARLY WAS NOT FUNCTIONING PROPERLY WHEN WE COMPARED IT TO AN ANOTHER LAG SCREW INSERTER WE HAD IN THE AREA. ULTIMATELY, THIS LED TO SIGNIFICANT DELAYS AND THE PATIENT BEING UNDER ANESTHESIA FOR A LONGER PERIOD OF TIME."

  Patient problems: Insufficient Information

  MAUDE report 16986970 ↗
• MalfunctionMar 14, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN 5030-000 LAG SCREW INSERTER BROKE DURING A PROCEDURE (INTRAMEDULLARY RODDING TROCHANTERIC FRACTURE). "CASE WAS COMPLETED BY USING PAST METHOD OF 2-3 FINGER TIGHTENING IN STEAD OF TORQUE LIMITING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757249 ↗
• MalfunctionFeb 7, 2022Loose or Intermittent Connection; Material Separation

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 5030-000 MULTIPLE PIECES OF THE LAG SCREW INSERTER HANDLE LOOSENED AND FELL APART. THIS WAS DISCOVERED DURING USE IN A TROCH NAIL PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13472328 ↗