NA 2178-63-174Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION STRAIGHT REAMER 14mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy M.B.T. straight reamer is a surgical instrument used to shape bone during hip revision surgery. The 31 reports describe reamers and their handles wearing out, bending, or dulling so they no longer lock properly to the adapter and T-handle, sometimes spinning freely or slipping apart at first resistance. Most involved no harm to the patient, though some mention delays during surgery. There were no deaths or 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295096313), received between Jul 27, 2017 and Mar 22, 2023 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (9 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 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent9
- Material Deformation8
- Naturally Worn8
- Device-Device Incompatibility4
- Dull, Blunt4
- Loose or Intermittent Connection3
- Appropriate Device Problem Term/Code Not Available2
- Failure to Cut2
Patient problems
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions5
- No Information3
- Not Applicable2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
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 16590872 ↗MalfunctionNov 17, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CONNECTION END OF THESE PARTS IS WORN AND NEEDS REPLACING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829216 ↗MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent
INSTRUMENTS ARE WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11825380 ↗MalfunctionDec 29, 2020Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility
IT WAS REPORTED THAT T HANDLE, CHUCKS, AND REAMERS ARE ALL DULL AND DO NOT STAY LOCKED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11090002 ↗MalfunctionDec 21, 2020Failure to Cut; Material Twisted/Bent; Naturally Worn; Failure to Cut; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11046285 ↗MalfunctionDec 17, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ALL REAMERS WERE LOOSE ON THE ADAPTERS AND SPUN FREELY. ADAPTER WOULD SPIN FREELY WHEN ATTACHED TO REAMERS OR ANY OTHER ATTACHMENT. T-HANDLE WAS ALSO LOOSE. ATTACHMENT POINT SEEMS TO BE WEAK AND CAME FREE AT FIRST SIGN OF RESISTANCE. NO PIECES BROKE OFF IN PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 AS A RESULT OF DEPUY INSTRUMENTS NOT FUNCTIONING PROPERLY.
Patient problems: Insufficient Information
MAUDE report 11027837 ↗MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, HAD COMPLAINTS THEY ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241212 ↗MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, HAD COMPLAINTS THEY ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241211 ↗MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS. HAD COMPLAINTS THEY ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240794 ↗MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS. HAD COMPLAINTS. THEY ARE STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240793 ↗MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT CHECK TOLERANCE ON HUB END COMPLAINTS NOT FITTING PROPERLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9238493 ↗MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.
Patient problems: Not Applicable
MAUDE report 9152467 ↗MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.
Patient problems: Not Applicable
MAUDE report 9151662 ↗MalfunctionSep 17, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS WERE DETERMINED TO BE WORN AND IN NEED OF REPLACEMENT UPON INSPECTION. SHIP REPLACEMENTS P1 TO (B)(6) MEDICAL CENTER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9075958 ↗MalfunctionSep 17, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE REAMERS, T-HANDLE, AND ADAPTORS CONNECTIONS ARE WORN. THE WRENCH WAS BENT. THE VIEW PLATE WAS CRACKED INTO TWO PIECES AND ALL INSTRUMENTS NEEDS REPLACEMENT. THESE ARE ALL OUT OF OFFICE SETS REPLACED TO CHARLOTTE OFFICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9075884 ↗MalfunctionJul 17, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT HUDSON/REAMERS WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8799823 ↗MalfunctionFeb 15, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation
IT WAS REPORTED THAT THE SIZE 10-18 MBT REVISION REAMERS ARE DULL AND SKIPPING ON ADAPTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345066 ↗MalfunctionFeb 15, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation
IT WAS REPORTED THAT THE SIZE 10-18 MBT REVISION REAMERS ARE DULL AND SKIPPING ON ADAPTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345039 ↗MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE REAMERS WERE STRIPPED AND DID NOT HOLD ONTO THE CHUCK. NO SURGICAL DELAY HAPPENED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8330809 ↗MalfunctionDec 3, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE ROUNDED OUT AND WOULD NOT STAY LOCKED IN THE HUDSON ADAPTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8124094 ↗MalfunctionAug 30, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE REAMER IS STRIPPED ON THE TIP THAT SNAPS INTO THE ADAPTER. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7832426 ↗MalfunctionJul 10, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS NEED A REPAIR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673055 ↗MalfunctionJul 6, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE REAMERS WAS STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7666049 ↗MalfunctionMay 29, 2018Defective Component; Mechanical Jam; Defective Component; Mechanical Jam
IT WAS REPORTED THAT THE 14MM IM ROD SLEEVE GDE WOULD NOT SLIDE OVER THE 14MM REAMER. THE SURGEON TRIED IMPACTING IT OVER THE REAMER SHAFT AND THE SLEEVE BECAME LODGED. THE SLEEVE WAS UNABLE TO BE ADVANCED OR REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7548976 ↗MalfunctionMay 2, 2018Loose or Intermittent Connection; Device-Device Incompatibility; Loose or Intermittent Connection; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM TIGHTENING DEVICE IS STUCK AND WILL NOT TURN. REAMER ADAPTER WILL NOT HOLD THE REAMERS. REAMER ADAPTER T HANDLE WILL NOT HOLD THE REAMERS. ALL OF THE REAMERS WRITTEN UP WILL NOT STAY CONNECTED IN THE ADAPTER; THEY SLIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7479223 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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