NA 2178-63-117Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION TIBIAL 2 DEGREE BROACH 61mm · 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 10603295096146), received between Jun 25, 2018 and Oct 25, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
- Material Twisted/Bent2
- Component Missing1
Patient problems
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE RED RUBBER TIP RIPPED NOT ALIGNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9239537 ↗MalfunctionSep 3, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STEM TRIALS WILL NOT CONNECT TO BROACHES. NEEDS REPLACEMENT VIA FEDEX P1 TO MUSC.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957422 ↗MalfunctionJun 21, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING REVISION TKA THE HUDSON ADAPTOR CONTINUED TO FAIL UNDER TORQUE. ALSO THE 61 TIBIAL SLEEVE BROACH WOULD NOT ACCEPT THE PILOT. BOTH ITEMS ARE WORN AND NEED REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8724168 ↗MalfunctionJan 11, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BROACH WOULD NOT ACCEPT A STEM TRIAL BECAUSE THE RUBBER GASKET WAS OUT OF ITS NORMAL POSITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8239150 ↗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 8019113 ↗MalfunctionOct 17, 2018Device-Device Incompatibility; Device-Device Incompatibility
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 7975225 ↗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 7635328 ↗
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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