NA 2274-32-000Recalls & reported problems
Depuy (Ireland) · T-HANDLE W/FEMALE HUDSON · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295109167), received between Sep 21, 2017 and Feb 2, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
- Connection Problem1
- Crack1
- Device-Device Incompatibility1
- Mechanical Jam1
- Physical Resistance/Sticking1
Patient problems
- No Information3
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY VIA THA WITH S-ROM REAMER AND T HANDLE IN QUESTION. DURING THE SURGERY, IT WAS USED AS A STARTER BY CONNECTING S-ROM REAMER AND T-HANDLE, BUT THE CONNECTION SOMETIMES CAME OFF, MAKING IT DIFFICULT TO USE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18634930 ↗MalfunctionFeb 12, 2019Connection Problem; Mechanical Jam; Physical Resistance/Sticking; Connection Problem; Mechanical Jam; Physical Resistance/Sticking
IT WAS REPORTED THAT THE METAL T HANDLE WOULD NOT ATTACH CORRECTLY TO REAMERS. THE SLIDING ATTACHMENT ON THE T-HANDLE KEPT GETTING STUCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8332149 ↗MalfunctionDec 18, 2017Break; Break
IT WAS REPORTED THAT ORTHOKIT SPECIALIST FOUND ONE BROKEN DEVICE DURING INSPECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7125161 ↗MalfunctionSep 21, 2017Crack; Crack
IT WAS REPORTED THAT THE ONE TAB OF THE T-HANDLE (B)(4) BROKE OFF AND ONE GOT CRACKED. FOR INSTRUMENT (B)(4) BOTH TABS BROKE OFF.
Patient problems: No Information
MAUDE report 6882366 ↗MalfunctionSep 21, 2017Break; Break
IT WAS REPORTED THAT THE ONE TAB OF THE T-HANDLE (AG2017737) BROKE OFF AND ONE GOT CRACKED. FOR INSTRUMENT (AG0605) BOTH TABS BROKE OFF.
Patient problems: No Information
MAUDE report 6882352 ↗MalfunctionSep 21, 2017Break; Break
IT WAS REPORTED THAT ONE TAB BROKE OFF AND ONE CRACKED.
Patient problems: No Information
MAUDE report 6882122 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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