LOCKING TOOL, GALILEO® LAG SCREW 0456-100Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665021448), received between Sep 26, 2022 and Jun 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 5/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT WHILE USING AN 0456-100 LAG SCREW, A 0462-000 CAPTURING ROD, AND A 0463-000 LAG SCREW INSERTER, FIRM RESISTANCE IS IMMEDIATELY FELT WHEN ATTEMPTING TO LOCK THE LAG SCREW WELL BEFORE RESISTANCE SHOULD BE MET. THIS OCCURRED DURING A HIP FRACTURE WITH IM NAIL PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19483886 ↗MalfunctionSep 26, 2022Break
ON 9/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0456-100 LOCKING TOOL, GALILEO® LAG SCREW HAD AN ISSUE. DURING A TROCHERANTIC FEMUR/TROCH NAIL PROCEDURE ON (B)(6) 2022, THE GALILEO LAG SCREW INSERTER BROKE WHILE INSERTING A LAG SCREW ON A TROCHANTERIC FEMUR FRACTURE. THE INSERTER BROKE WHERE THE LAG SCREW ATTACHED TO THE BLACK HANDLE. A PIECE BROKE OFF INSIDE THE PATIENT, THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484297 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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