CAPTURING ROD NUT, GALILEO® LAG SCREW 5046-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848665039160), received between May 6, 2024 and May 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 22106759 ↗
• MalfunctionMar 12, 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 21585854 ↗
• MalfunctionJan 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) 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 21114260 ↗
• 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 19533388 ↗
• MalfunctionJun 13, 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 19532976 ↗
• 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 19329915 ↗
• MalfunctionMay 6, 2024Device Damaged by Another Device; Device Damaged by Another Device

  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 19250272 ↗