T-HANDLE, CANNULATED, SILICONE, LARGE HUDSON 0468Recalls & reported problems
Advanced Orthopaedic Solutions, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848665001969), received between Jun 10, 2024 and Jul 17, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Break; Break
ON 6/24/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS- (B)(4) THAT AN 0468-000 T-HANDLE, CANNULATED, LARGE HUDSON BROKE WHEN TIGHTENING THE TROCH NAIL TO THE JIG. THERE WERE NO PIECES BREAKING OFF INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. A PHOTO IS ATTACHED. THIS WAS DISCOVERED DURING AN INTERTROCHANTERIC FX IM NAIL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760175 ↗MalfunctionJun 19, 2024Break; Break
ON 11/03/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT BOTH THE 0467-000 BLUE STRAIGHT HANDLE AND 0468-000 BLUE T HANDLE WERE HAVING ISSUES WHEN TRYING TO REMOVE THE NAIL HOLDING BOLT. BOTH OF THE HANDLES KEPT SPINNING WITHOUT SPINNING THE BALL HEX DRIVER. A DIFFERENT TROCH NAIL SET, AND NEW HANDLE WERE USED TO REMOVE THE BOLT. REQUESTED ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567034 ↗MalfunctionJun 13, 2024Break; Break
IT WAS REPORTED ON 03/21/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0468-000 T-HANDLE BROKE. CASE INVOLVEMENT, NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19530628 ↗MalfunctionJun 10, 2024Break; Break
IT WAS REPORTED THAT THREE 0468-000 T-HANDLES ARE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19505664 ↗
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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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