NA 2178-63-115Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL 2 DEGREE BROACH 53mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295096122), received between Aug 10, 2017 and Dec 28, 2021 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility3
- Break1
- Component Missing1
- Device Issue1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE BUSHING ON THE TIBIAL BROACH IS DAMAGED, WILL NOT ACCEPT A STEM TRIAL. BOTH MODIFIED ADAPTERS ARE STRIPED. 16MM HUDSON IS STRIPED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13092640 ↗MalfunctionSep 3, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM TRIALS WILL NOT CONNECT TO BROACHES. NEEDS REPLACEMENT VIA (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957428 ↗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 8019146 ↗MalfunctionOct 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE 4 BROACHES FOR THE TIBIAL SLEEVES DO NOT ATTACH TO THE UNIVERSAL SLEEVE TRIALS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7970077 ↗MalfunctionJun 25, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE TIBIAL BROACHES ARE MISSING THE RUBBER RING INSIDE THE BROACHES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7635347 ↗MalfunctionApr 2, 2018Device Issue; Device Issue
BROACH WOULDN¿T CONNECT TO HANDLE IN THEATRE YESTERDAY AFTERNOON. PATIENT WAS NOT HARMED AND NO DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7388637 ↗MalfunctionAug 10, 2017Break; Break
IT WAS REPORTED THAT THE STEM TRIAL WOULD NOT FULLY ENGAGE INTO SLEEVE BROACH. RUBBER RING APPEARS TO HAVE BEEN DEFORMED.
Patient problems: No Information
MAUDE report 6785476 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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