COMFORT T-HANDLE, CANNULATED, LARGE HUDSON ADAPTER 0468-100Recalls & 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 00848665037517), received between May 24, 2024 and Jun 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
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 11, 2024Break; Break
IT WAS REPORTED ON 02/14/2023 BY A SALES REPRESENTATIVE VIA SEMS 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 19509393 ↗MalfunctionMay 24, 2024Break; Break
ON 01/10/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE 1239-100 LOCKING KNOB (LINE #1) IS STUCK INTO THE 1235-100 INSERTION GUIDE (LINE #2) AND THE 0468-100 T-HANDLE (LINE #3) BROKE WHILE TRYING TO REMOVE THE LOCKING KNOB.
Patient problems: Insufficient Information
MAUDE report 19398050 ↗
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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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