NA 96-1686Recalls & reported problems
Depuy (Ireland) · UNIVERSAL REVISION FEMORAL BROACH 46mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295239840), received between Jul 17, 2018 and May 16, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Connection Problem1
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Break; Break
IT WAS REPORTED THE RUBBER SEALS ON SEVERAL TRIALS WERE TORN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036540 ↗MalfunctionMar 1, 2022Break; Break
THE TWO INSTRUMENTS ARE BROKEN. DISCOVERY WAS MADE AFTER STERILIZATION PROCESS. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13635851 ↗MalfunctionNov 25, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
PROBLEM: IT IS VERY DIFFICULT TO CLEAN THE BROACH SLEEVE AND THE GASKETS. ACCORDING TO ATTACHED PICTURES THE BROACH SLEEVE IS STILL DIRTY AFTER CLEANING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9369615 ↗MalfunctionJul 17, 2018Connection Problem; Connection Problem
WHEN BROACHING THE FEMUR, THE FLUTED TRIAL STEM WOULD NOT FIT WITH THE 46MM UNIVERSAL REVISION FEMORAL BROACH. THE TRIALS FITTED ALL OTHER BROACHES, JUST NOT THE 46MM BROACH. IT WOULD NOT ENGAGE WITH THE LOCKING MECHANISM. THERE WAS MAYBE A ONE MINUTE DELAY IN SURGERY. AT 1 MINUTE DELAY TO PROCEDURE.
Patient problems: No Code Available
MAUDE report 7693484 ↗
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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