NA 2178-63-109Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL BROACH 29mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy MBT Revision Tibial Broach is a surgical broach. The 40 adverse event reports describe malfunctions such as missing parts, device-device incompatibility, breakage, and bent or deformed parts; accounts also mention dull or worn instruments, poor fit with handles, and trouble securing stem trials. There were no deaths and no injuries. 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295096078), received between Jul 18, 2017 and Oct 10, 2024 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Component Missing” (21 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
- Component Missing21
- Device-Device Incompatibility7
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Material Deformation2
- Material Twisted/Bent2
- Scratched Material2
- Connection Problem1
Patient problems
- No Consequences Or Impact To Patient33
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- No Code Available2
- No Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2024, THE BROACH IS WARPED AND DOES NOT FIT ON HANDLE. THE METAL TIP BROKE OFF ON WRENCH. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20417725 ↗MalfunctionJan 4, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL STEM IS UNABLE TO LOCK ON TO BROACH HANDLE. ITEM DEFECTIVE. NO MISSING PIECES. NO FURTHER INFORMATION IS AVAILABLE. NOT USED IN SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13151451 ↗MalfunctionOct 13, 2021Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
"CONNECTION IN THE SLEEVE BROACH WAS NICKED BY THE SAW BLADE. IT WASN'T ABLE TO HITCH ON TO THE HANDLE AFTER THAT."
Patient problems: Insufficient Information
MAUDE report 12624450 ↗MalfunctionApr 26, 2021Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE BROACHES ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726957 ↗MalfunctionOct 2, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT D961673 IS WORN AND NEEDS TO BE REPLACED, THE BLACK END THAT GOES OVER THE IMPLANT TO TIGHTEN WAS SLIPPING WHEN THE SURGEON WAS PUTTING IMPLANTS TOGETHER. PRODUCT D217863109 AND D217863111 ARE NOT HOLDING STEM TRIALS WELL DUE TO THE WEAR AT THE CONNECTION SITE. NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10623941 ↗MalfunctionMay 11, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TWO TIBIAL BROACHES WOULDN¿T SECURELY HOLD THE STEM TRIALS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10043730 ↗MalfunctionNov 20, 2019Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE BROACH WAS VERY DULL AND NEEDS TO BE REPLACED. SHIP REPLACEMENT TO EAST COOPER FOR P1 DELIVERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9348210 ↗MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility
REFURBISH WON'T ATTACH TO BROACH HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9234227 ↗MalfunctionMay 28, 2019Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent
AN MBT SLEEVE WAS MISSING THE ORANGE RING IN FEMALE PIECE THAT ATTACHES TO STEM TRIALS. NO TIME WAS ADDED TO THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8646030 ↗MalfunctionMay 10, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE RUBBER GASKET IS TORN IN 29MM SIGMA TIBIAL BROACH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8601002 ↗MalfunctionApr 2, 2019Failure to Clean Adequately; Failure to Clean Adequately
REV. G) FOR INSTRUMENTS OF THIS SYSTEM AS THERE IS A RUBBER-O-RING IN THE INSTRUMENT SO THAT THE TRIAL STEM WILL HAVE A TIGHT FIT. BECAUSE OF THIS THE INSTRUMENT IS DIFFICULT TO CLEAN. THE GIVEN REF IS AN EXAMPLE. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8475931 ↗MalfunctionMar 29, 2019Component Missing; Material Deformation; Naturally Worn; Component Missing; Material Deformation; Naturally Worn
THE 2 INSTRUMENTS ARE WORN AND THE COUPLING MECHANISM HAS BECOME FAULTY DUE TO THE STEM RETAINING RING IN THE COUPLING MECHANISM, HAVING BEEN LOST. THIS DID NOT OCCUR DURING A PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465414 ↗MalfunctionFeb 4, 2019Fitting Problem; Fitting Problem
THE STEM TRIAL DOES NOT CORRECTLY ENGAGE WITH BROACH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8301177 ↗MalfunctionJan 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
THE TIBIAL BROACH COULD NOT HOLD STEM TRIAL IN PLACE. THE SPRING INSIDE WAS LOOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8288864 ↗MalfunctionJan 17, 2019Component Missing; Component Missing
WORN INSTRUMENTS, NEED TO BE REPLACED. SOME OF THE "O RINGS" ARE MISSING FROM THE REAMERS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8258608 ↗MalfunctionOct 30, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DOCTOR AND SCRUB NURSE STRUGGLED CONNECTING BROACHES AND REAMERS TO TRIAL STEMS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8019233 ↗MalfunctionAug 13, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7777230 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767743 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767715 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767626 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767620 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767095 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767085 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767063 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE 29 SLEEVE BROACH IS MISSING WASHER SO STEM TRIAL WILL NOT STAY ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7767051 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 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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