NA 2178-63-137Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION T-HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy M.B.T. Revision T-Handle is a manual surgical handle used in knee replacement procedures. Its 105 reports are all malfunction reports, mostly describing the handle not connecting or gripping reamers properly, worn or stripped parts, and bent or broken parts. There were no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10603295096269), received between Jul 10, 2017 and Jul 8, 2026 — classified as 105 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (38 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
- Device-Device Incompatibility38
- Naturally Worn22
- Material Twisted/Bent21
- Break20
- Material Deformation12
- Appropriate Device Problem Term/Code Not Available9
- Connection Problem5
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Consequences Or Impact To Patient59
- No Clinical Signs, Symptoms or Conditions25
- No Information9
- Not Applicable8
- No Code Available6
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753027 ↗MalfunctionJan 7, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE SROM HINGE KNEE INSTRUMENTS WERE FOUND TO BE WORN AND STRIPPED. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992187 ↗MalfunctionJan 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE T-HANDLE AND HUDSON ADAPTOR DID NOT CONNECT PROPERLY TO REAMERS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21162005 ↗MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE T-HANDLE AND HUDSON ADAPTOR DO NOT CONNECT PROPERLY TO REAMERS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21161954 ↗MalfunctionOct 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE UNIVERSAL HANDLE TIP BROKE, PATELLA CLAMP STICKS WHEN LOOSENING , T-HANDLE DOES NOT GRIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17881731 ↗MalfunctionJul 19, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE MBT REVISION REAMER T HANDLE WAS STRIPPED AND WILL NOT HOLD REAMERS WHILE WORKING INTRAOPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17352790 ↗MalfunctionJun 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE WRENCHES WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224667 ↗MalfunctionApr 26, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT T HANDLE WILL NO LONGER HOLD THE REAMERS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16816835 ↗MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMERS NO LONGER ATTACH TO ADAPTOR AND T HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16590846 ↗MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMERS NO LONGER ATTACH TO ADAPTOR AND T HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16590838 ↗MalfunctionMar 14, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE T HANDLE DOESN¿T ATTACH TO ANYTHING ANYMORE. IT¿S BEEN STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16541595 ↗MalfunctionFeb 7, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE T HANDLE AND ADAPTERS BOTH STRIPPED. NUB A CLAMP DAMAGED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16311193 ↗MalfunctionAug 9, 2022Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE LCS COMPONENTS ARE NOT ENGAGING PROPERLY. THE END OF BROACH INSERTER IS CRACKED. THE BACK END OF DEPTH GAUGE KEEPS FALLING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15191234 ↗MalfunctionMar 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT BOTH OF THE T-HANDLES LISTED BELOW ARE STRIPPED AND WILL NOT HOLD A REAMER FOR THE DOCTOR TO PERFORM PROPER REAMING. THE SURGEON REQUESTED A NEW ONE TO REPLACE. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED. THE REAMER IS STRIPPED AND WILL NOT HOLD A T-HANDLE FOR PROPER REAMING. SURGEON HAS REQUESTED TO BE REPLACED. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13711482 ↗MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR HAD ISSUES WITH THE MBT REVISION REAMERS. THE HUDSON ADAPTER AND T-HANDLE FOR THE REAMERS WERE BOTH SLIPPING, MAKING THEM BOTH INOPERABLE. SURGICAL DELAY OF 5 MINUTES OCCURRED.
Patient problems: Insufficient Information
MAUDE report 13625214 ↗MalfunctionDec 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
T-HANDLE AND HUDSON ADAPTER ARE ALLOWING REAMERS TO SLIP IN THE COUPLING AND LOCK MAKING IT VERY DIFFICULT TO DISCONNECT. WRENCH WILL NOT LOCK OR TIGHTEN PROPERLY. MBT IMPACTOR BROKE ON CONTACT SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13025198 ↗MalfunctionSep 15, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT WHILE TRYING TO REAM THE CANAL BY HAND THE T-HANDLE KEPT ON SLIPPING ON THE REAMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474721 ↗MalfunctionJul 30, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REVISION REAMER AND T-HANDLE WERE DIFFICULT TO SEPARATE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12253502 ↗MalfunctionMay 3, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT WHILE ATTEMPTING TO PREPARE THE FEMUR FOR A FEMORAL SLEEVE, THE ADAPTER, SHAFT AND SUBSEQUENTLY T-HANDLE WERE "SLIPPING". UPON INSPECTION AFTER THE PROCEDURE, WEAR IS NOTED ON EACH AND WILL BE SENT FOR REPLACEMENT. IT WAS ALSO REPORTED THAT A SEPARATE FORM WAS SUBMITTED FOR THE IMPLANTS. WITH A 2 MINUTES DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 11761009 ↗MalfunctionApr 30, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE MBT REAMERS WERE SLIPPING IN THE HUDSON ADAPTER AND T-HANDLE DURING THE CASE. AFTER THE CASE, THE INSTRUMENTS SHOWED WEAR DUE TO USAGE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11758419 ↗MalfunctionApr 7, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE T HANDLE IS STRIPPED AND NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11629815 ↗MalfunctionJan 28, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE TWO REAMERS FROM THE MBT REAMER SET ARE STARTING TO SHOW WEAR ON THE CONNECTION END. THE T-HANDLE AND MODIFIED HUDSON ADAPTER ARE ALSO SHOWING SIGNS OF ROUNDING OUT ON THE CONNECTION END. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11247647 ↗MalfunctionJan 25, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DOCTOR WAS NOT ABLE TO HOLD ONTO A REVISION FRAMER WITH T-HANDLE, THE BEARINGS MAY BE STRIPPED. ALL PIECES WERE RETRIEVED AND ARE BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11227477 ↗MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE T HANDLE DOES NOT COME OFF REAMER TIP. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11214832 ↗MalfunctionJan 20, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT T-HANDLE AND HUDSON ADAPTOR DO NOT STAY ATTACHED TO REAMER HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11201887 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- 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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