CORAIL L98412XRecalls & reported problems
Depuy (Ireland) · CORAIL HIP SYSTEM CORAIL REVISION BROACH, SIZE 12 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295394198), received between Oct 29, 2019 and Mar 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Break; Break
IT WAS REPORTED THAT THE BROACH BROKE. NO SERIOUS CONSEQUENCES AROSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914267 ↗MalfunctionOct 29, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PARTS WERE BROKEN. RECEIVED BROKEN PART FROM WAREHOUSE ON (B)(6) 2019. CUSTOMER NUMBER (B)(4). PEG PORTION OF CORAIL REVISION BROACH BENT DURING USE WITH KINCISE IMPACTOR (POWER TOOLS).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9250050 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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