CAPTURING ROD, GALILEO® LAG SCREW 5033-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00848665039177), received between Jun 27, 2022 and Aug 8, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON 07/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 5033-100 CAPTURING ROD ASSEMBLYS GALILEO LAG SCREW WAS LOADED ONTO THE HANDLE AND CAPTURE ROD. WHEN THE SCREW WAS ADVANCED OVER THE 3.2MMX 381MM GUIDE WIRE IT GOT STUCK. AFTER REMOVING THE GUIDE WIRE AND THEN READVANCING THE SCREW THE HANDLE WAS DISENGAGED FROM THE SCREW AND THE CAPTURE ROD WAS INSPECTED. THE TOP PORTION OF THE ROD WAS BROKEN OFF ON THE MAYO STAND. AN X-RAY WAS OBTAINED TO CONFIRM NO PORTION OF THE ROD WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL TIME OR ISSUES. ADDITIONAL INFORMATION WAS PROVIDED ON 07/24/2025 WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED DURING A INTERTROCHANTERIC FRACTURE. THE DEVICE BROKE AT THE THREADS WHERE THE NUT ATTACHES WHEN IT WAS PLACED OVER THE GUIDEWIRE. THE PATIENTS BONE WAS SOFT, ALL FRAGMENTS WERE RETRIEVED. THE CASES WAS COMPLETED USING A SECOND CAPTURING ROD FROM THE INSTRUMENT SET. THERE WERE NO MAJOR DELAYS, AND NO ADDITIONAL ANESTHESIA WAS DELIVERED.

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

  MAUDE report 22748413 ↗
• MalfunctionMay 29, 2025Break; Break

  ON 05/08/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 5033-100 CAPTURING ROD ASSEMBLY AND AN 5046-100 LAG SCREW CAPTURING ROD NUT BROKE. THIS OCCURRED DURING A CASE. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22106547 ↗
• MalfunctionMar 13, 2025Positioning Failure; Positioning Failure

  ON 02/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5046-100 LAG SCREW CAPTURING ROD NUT AND A 5033-100 CAPTURING ROD ASSEMBLY HAD AN ISSUE WITH NOT LOCKING THE LAG SCREW INTO THE NAIL AS DESIGNED AND HAD TO USE THE LOCKING END CAP INSTEAD. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593298 ↗
• MalfunctionFeb 13, 2025Break; Break

  ON 01/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARM GREEN BUTTON WAS DEFECTIVE AND DID NOT HOLD THE SHEATH SECURELY AND A 5033-100 GALILEO CAPTURING ROD END SNAPPED OFF WHEN THE SURGEON UNSCREWED THE ROD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374476 ↗
• 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 21114598 ↗
• MalfunctionOct 8, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06664365 THAT A 5033-100 CAPTURING ROD ASSEMBLY HAS A BROKEN FRAGMENT FROM CROSS-THREADING. IT IS BELIEVED THAT THIS HAPPENED IN A PREVIOUS CASE. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 20397189 ↗
• MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF A 5033-100 GALILEO CAPTURING ROD AND QTY. 2 OF A 5046-100 GALILEO ROD NUT HAD AN ISSUE BEFORE AND DURING A TROCH NAIL PROCEDURE ON (B)(6) 2023. WHEN ASSEMBLING THE LAG DRIVER ON THE BACK TABLE BEFORE THE CASE, THE CAPTURING ROD WOULD NOT THREAD INTO THE NUT. THEY PUT TOGETHER THE SECOND CAPTURING ROD AND NUT FOR THE CASE, WHICH WORKED FINE BEFORE THE PROCEDURE. HOWEVER, DURING THE SURGERY AFTER INSERTING THE LAG AND TRYING TO REMOVE THE NUT FROM THE INSERTER, IT WOULD NOT COME OFF WITH THE REMOVAL TOOL. THEY HAD TO USE PLIERS AND THEN THE CAPTURING ROD AND NUT WERE COMPROMISED LIKE THE ONES BEFORE THE CASE. NO PIECE BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED SUCCESSFULLY AND THE PATIENT WAS NOT INJURED. THIS HAPPENED OUTSIDE THE PATIENT AS WELL. THIS OCCURRED BEFORE USE AND DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533391 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 5/5/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 5033-100 CAPTURING ROD ASSEMBLY BROKE WHEN INSERTING A TELESCOPING LAG SCREW. THE CASE WAS COMPLETED BY REMOVING THE 1099-120 TELESCOPING LAG SCREW, 8001-055 CAPTURED CORTICAL SCREW, AND 8021-080 CANCELLOUS A/R SCREW AND USING NEW ONES WITH A NEW INSTRUMENT SET. THIS WAS DISCOVERED DURING A FEMUR INTRAMEDULLARY NAILING PROCEDURE ON (B)(6) 2023. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19509622 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED ON 02/14/2023 BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 5046-100 CAPTURING ROD, 5033-100 CAPTURING ROD, AND 0468-100 T-HANDLE BROKE DURING USE. CASE INVOLVEMENT, NO PATIENT EFFECT. NOTHING BROKE INSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509377 ↗
• MalfunctionJun 6, 2024Break; Break

  ON 10/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 5033-100 GALILEO CAPTURING ROD AND A 5046-100 GALILEO CAPTURING ROD NUT HAD AN ISSUE, THE LAG SCREW CAPTURING ROD BROKE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME ON (B)(6) 2022 WITH NO CASE/PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480337 ↗
• MalfunctionJun 5, 2024Break; Break

  ON 09/01/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A (2) 5033-100 CAPTURING RODS ARE DAMAGED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472215 ↗
• 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 19460590 ↗
• MalfunctionMay 16, 2024Break; Break

  ON 12/17/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 5033-100 GALILEO® CAPTURING ROD, A 5046-100 GALILEO® CAPTURING ROD NUT AND A 5030-000 GALILEO® LAG SCREW INSERTER WERE BROKEN OR MESSED UP / DAMAGED DURING A TROCH NAIL CASE ON (B)(6) 2021 AND COULD NOT BE REPAIRED IN THE FIELD. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. AN EMAIL WAS SENT TO THE SALES REPRESENTATIVE ON 12/28/21 FOR FURTHER CLARIFICATION AND TO FIND OUT HOW THE CASE WAS COMPLETED. ON 12/28/2021, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THAT THE CASE WAS DELAYED A FEW MINUTES AND THEY HAD TO OPEN ANOTHER TRAY TO COMPLETE THE SURGERY, ANOTHER EMAIL WAS SENT TO THE SALES REPRESENTATIVE ON 12/30/2021 TO FIND OUT IF THE DEVICE(S) BROKE INSIDE THE PATIENT AND IF ALL FRAGMENTS WERE RETRIEVED. ON 12/30/2021, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THAT THE DEVICE(S) BROKE WHEN THE SCRUB TECH WAS TRYING TO DISCONNECT THE PIECES. THIS DID NOT BREAK INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331034 ↗
• MalfunctionMay 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/21/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE 5033-100, GALILEO LAG SCREW CAPTURING ROD IS STUCK IN THE 5046-100 CAPTURING ROD NUT AND WOULD COME OUT CAUSING BOTH THE ROD NUT AND THE ROD TO BE STRIPPED. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329592 ↗
• MalfunctionMay 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06538177 THAT (2) 5033-100 CAPTURING RODS TIPS BROKE OFF IN THE 5046-100 CAPTURING ROD NUT. THIS OCCURRED DURING AN AOS TROCH NAIL WHILE INSERTING THE LAG SCREW FOR THE TORCH NAIL, THE TIP BROKE OFF WITH THE NUT THAT SCREWS ONTO THE BACK OF THE TOOL. THE SURGEON WAS ABLE TO REMOVE EVERYTHING SAFELY WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250332 ↗
• MalfunctionMay 6, 2024Break; Break

  ON 04/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) 5033-100 CAPTURING RODS TIPS BROKE OFF IN THE 5046-100 CAPTURING ROD NUT. THIS OCCURRED DURING AN AOS TROCH NAIL WHILE INSERTING THE LAG SCREW FOR THE TORCH NAIL, THE TIP BROKE OFF WITH THE NUT THAT SCREWS ONTO THE BACK OF THE TOOL. THE SURGEON WAS ABLE TO REMOVE EVERYTHING SAFELY WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250174 ↗
• MalfunctionApr 30, 2024Break; Break

  ON 04/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A LAG SCREW CAPTURING ROD (5033-100) AND A LAG SCREW CAPTURING ROD NUT (5046-100) WERE BROKEN. THE TIP OF THE ROD WAS BROKEN OFF WITHIN THE NUT AND WAS UNUSABLE. THIS MUST HAVE HAPPENED IN A PREVIOUS CASE. HOWEVER, DURING THE CASE, THE SCREW CAPTURING ROD, LONG FOR THE STRAIGHT HANDLE (0477-000) BROKE WHILE THE SURGEON WAS USING IT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19214368 ↗
• MalfunctionOct 5, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06023115 THAT AN 5033-100 GALILEO® CAPTURING ROD BROKE. THIS OCCURRED DURING A CASE, ALL FRAGMENTS WERE RETRIEVED AND THE CASE CONTINUED USING ANOTHER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17876557 ↗
• InjuryMay 23, 2023Break; Failure to Advance; Break; Failure to Advance

  ON 04/26/2023, 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 16986989 ↗
• MalfunctionJul 25, 2022Break; Physical Resistance/Sticking

  IT WAS REPORTED ON 07/08/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN 5033-100 GALILEO CAPTURING ROD BROKE. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE. PER FACILITY: "AFTER THE SURGEON HAD SET THE LAG SCREW, HE TRIED TO REMOVE THE NUT ON THE END OF THE SCREW DRIVER - ATTACHED TO THE SCREW CAPTURE. IT WAS STUCK, SO HE USED A PAIR OF PLIERS TO LOOSEN IT. IN THE PROCESS, THE CAPTURE BROKE INSIDE THE NUT. IDEA WAS THAT IT HAD BEEN CROSS THREADED. ALL BROKEN PIECES WERE RECOVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093749 ↗
• MalfunctionJun 27, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A 5046-100 GALILEO® CAPTURING ROD NUT AND A 5033-100 GALILEO® CAPTURING ROD HAD AN ISSUE. DURING A TROCH NAIL CASE ON (B)(6) 2022, THE BACK OF THE LAG SCREW CAPTURING ROD SNAPPED OFF WHEN THE SURGEON WENT TO REMOVE THE NUT AFTER INSERTION OF THE LAG SCREW. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828542 ↗