CORAIL L20409Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295258117), received between Oct 13, 2017 and Apr 7, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (25 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE IN TWO PIECES AND IS IN NEED OF REPLACEMENT THERE APPEAR TO BE NO NEGATIVE PATIENT OUTCOME OR SURGICAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808766 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT WHEN USING THE DRILL BIT TO OPEN THE HOLE IN THE ACETABULUM, IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400258 ↗
• MalfunctionJul 8, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  BROACH WILL NOT CONNECT TO THE TRAIL NECKS, THE TOP OF BROACH IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689153 ↗
• MalfunctionFeb 29, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE ENGAGEMENT PIN ON THE END OF THE BROACH IS BENT AND NECK SEGMENTS CAN¿T ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813412 ↗
• MalfunctionJan 2, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  DUE TO FREQUENT USE, THE CONNECTING PIECE OF THE BROACH IS WORN OUT. IT IS NO LONGER POSSIBLE TO ATTACH THE NECK SEGMENT CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18431630 ↗
• MalfunctionNov 16, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE BROACH CORAIL AMT 9 DOES NOT FIT CORRECTLY INTO THE CORRESPONDING TEST NECKS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154123 ↗
• MalfunctionNov 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  KHO NECK TRIAL GOT STUCK ON TRIAL BROACH AND WAS DIFFICULT TO REMOVE WHEN TRIALING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147764 ↗
• MalfunctionOct 18, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STAFF WAS UNABLE TO FIT BROACH HANDLE ONTO SIZE 9 BROACH, CHANGE IN SHAPE TO OVAL, HANDLE COULDN'T ATTACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956687 ↗
• MalfunctionAug 23, 2023Corroded; Corroded

  IT WAS REPORTED THAT DEVICE HAS RUST SPOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608278 ↗
• MalfunctionFeb 24, 2023Failure to Cut; Naturally Worn; Scratched Material; Failure to Cut; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BLUNT AND NEEDED TO BE UPGRADED. THERE WAS NO DELAY IN SURGERY. IT WAS REPORTED TODAY ((B)(6) 2023). THE HEADS ARE ALL SCRATCHED AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434910 ↗
• MalfunctionFeb 7, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE ATTACHMENT FOR THE SIZE 9 CORAIL BROACH IS WARPED. NECK SEGMENTS WILL NOT SECURELY FIT ON AND THE SURGEON IS UNABLE TO TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311036 ↗
• MalfunctionNov 30, 2022Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886486 ↗
• MalfunctionNov 30, 2022Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886265 ↗
• MalfunctionMar 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THEY WERE UNABLE TO SEAT A TRIAL NECK IN CORAIL BROACH NUMBER 9 DURING SURGERY AND HAD TO USE ANOTHER SET. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693025 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROSTHESES / INSTRUMENTS FROM THE DPS JOINTS FRANCHISE ARE SHOWING (COMING OUT) SOOT AFTER THE STERILIZATION PROCESS AND THAT THE BOXES ALSO HAVE DARK SPOTS ON THE TRAYS WHICH, ACCORDING TO THE HOSPITAL, REPRESENTS THAT THE MATERIAL IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454438 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PROSTHESES / INSTRUMENTS FROM THE DPS JOINTS FRANCHISE ARE SHOWING (COMING OUT) SOOT AFTER THE STERILIZATION PROCESS AND THAT THE BOXES ALSO HAVE DARK SPOTS ON THE TRAYS WHICH, ACCORDING TO THE HOSPITAL, REPRESENTS THAT THE MATERIAL IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453967 ↗
• MalfunctionDec 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE CONNECTS TO AS WELL AS NECK SEGMENTS ON THE BROACH WILL NOT CONNECT APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916075 ↗
• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL CORAIL INSTRUMENTATION IS NOT CONTACTING CORRECTLY. THEY ARE STIFF TO PUT TOGETHER AND ALSO STIFF WHEN REMOVING. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894329 ↗
• MalfunctionNov 19, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HANDLE BROKE, BUT DID NOT BREAK INTO TWO OR MORE PIECES. THE INSTRUMENT WAS NOT USED DURING SURGERY AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843562 ↗
• MalfunctionSep 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  BROACH FAILED TO ENGAGE ONTO BROACH HANDLE DURING OPERATION. SPARE SET OPENED, OPERATION COMPLETED SUCCESSFULLY. INSTRUMENTS REPORTED AND ISOLATED. NO ADVERSE OUTCOME REPORTED. BROACH FAILED TO ENGAGE ONTO BROACH HANDLE. SPARE SET OPENED, OPERATION COMPLETED SUCCESSFULLY. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547996 ↗
• MalfunctionJul 21, 2021Break; Break

  DURING SURGERY, THE SIZE 9 CORAIL BROACH BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203055 ↗
• MalfunctionApr 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A T-HANDLE IS CRACKED. ADDITIONALLY, A SIZE 9 CORAIL BROACH BECAME STUCK IN KINCISE BROACH ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733818 ↗
• MalfunctionApr 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  CORAIL BROACH WOULD NOT ACCEPT NECK TRIAL SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671468 ↗
• MalfunctionMar 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  L20409 WILL NOT EASILY ATTACH TO BROACH HANDLE. EVERY OTHER BROACH IS CONNECTING FINE AND THE BROACH HANDLE IS NEW. THE ISSUE IS WITH THE MALE CONNECTION OF THE L20409. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422456 ↗
• MalfunctionJan 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON WAS UNABLE TO ATTACH A CORAIL NECK SEGMENT TO THE SIZE 9 CORAIL BROACH IN SITU PRIOR TO TRIAL STAGE DURING HIS THR PROCEDURE. THE SURGEON TRIED THE SAME NECK SEGMENT WITH OTHER CORAIL BROACHED EXTERNAL TO THE PATIENT AND THEY ALL FUNCTIONED NORMALLY. HE WAS ABLE TO CONCLUDE THE ISSUE WAS WITH THE CORAIL BROACH AND NOT THE NECK SEGMENT/TRIAL. THE HOSPITAL HAD A SPARE CORAIL BROACH/NECK TRIAL TRAY ON HAND AND THEREFORE THERE WAS NO DELAY IN PROCEDURE. CASE COMPLETED SUCCESSFULLY AS PLANNED. FAULTY BROACH AVAILABLE FOR COLLECTION IMMEDIATELY AT THE ENTRANCE TO CSSD (USUAL LOAN SET COLLECTION POINT). NO FURTHER INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108246 ↗