CORAIL L20410Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295258124), received between Jul 6, 2017 and Jul 22, 2025 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (27 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A BHA SURGERY WITH THE DEVICE IN QUESTION. IN THE SURGERY, WHEN THE CALCAR REAMER WAS APPLIED, THE AXIAL DIRECTION MAY HAVE SHIFTED, AND IT BECAME HOT. THERE WERE BLACK MARKS OF RUBBING. AFTER THAT, THE CONNECTION WITH THE TRIAL NECK AND RASP HANDLE DID NOT CONNECT PROPERLY, AND THE DEVICE IN QUESTION COULD NOT BE USED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569739 ↗
• MalfunctionApr 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH GETS STUCK ON BROACH HANDLE AND UNABLE TO TAKE THEM APART WITHOUT EXCESSIVE FORCE. BROACH GETS STUCK ON NECK TRIALS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807102 ↗
• MalfunctionMar 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT GETS STUCK IN THE HANDLE. THE ISSUE WAS SEEN IN THE STERILE PROCESSING DEPARTMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604833 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE CONNECTION POINT OF THE BROACH HAD GROOVES/STRIATION MARKS IN IT BELIEVED TO HAVE BEEN CAUSED BY THE CALCAR REAMER AT SOME POINT. THIS MAD IT ROUGHENED AND THEREFORE DIFFICULT TO ATTACH TO THE BROACH HANDLE. THE SURGEON MANAGED TO FORCE THE BROACH ON AND OFF THE BROACH HANDLE TO BE ABLE TO USE IT AND THEN PROGRESS TO THE NEXT SIZE BROACH. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT. THE SURGERY WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912672 ↗
• MalfunctionOct 9, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE STEM ON THE BROACH HAS BENT AND WILL NOT ATTACH TO THE BROACH HANDLE OR ACCEPT A NECK TRIAL. THE SURGEON WENT TO THE NEXT SIZE UP. THERE WAS A SURGICAL DELAY OF FOUR (4) MINUTES. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406775 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024 , THE SURGEON WAS UNABLE TO FIT NECK TRIAL ONTO CORAIL SZ 10 BROACH. AN ALTERNATE SET WAS USED TO COMPLETE THE PROCEDURE WITH LITTLE TO NO TIME LOST. NO PATIENT CONSEQUENCE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346565 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT THE BROACH NECK ATTACHMENT SHEARED OFF. THERE WAS A 5 MINUTE DELAY TO SURGERY DUE TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211686 ↗
• MalfunctionFeb 22, 2024Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756815 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WERE NO ADVERSE CONSEQUENCES. IT ALSO STATES SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493735 ↗
• 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 18431619 ↗
• MalfunctionNov 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT DOESN¿T ACCEPT THE NECK TRIAL, HOWEVER DOES STILL ACCEPT THE BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215776 ↗
• MalfunctionSep 21, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE BROACH BROKE DUE TO WEAR AND TEAR. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788043 ↗
• MalfunctionMay 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO ATTACH BROACH HANDLE/TRIAL NECK TO THE BROACH. SURGEON THREW AWAY BROACH IN SHARPS BIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914614 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538799 ↗
• 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 REPORT TODAY ((B)(6) 2023). THE HEADS ARE ALL SCRATCHED AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434916 ↗
• MalfunctionJun 16, 2022Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE METAL POST WHICH SLOTS INTO THE BROACH HANDLE IS DAMAGED AND WAS DISCOVERED DURING RANDOM SET INSPECTIONS. NONE OF THE BROKEN INSTRUMENTS HAVE CAUSED ANY ISSUED WITH PATIENTS OR SURGERY AS THEY WERE IDENTIFIED PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712992 ↗
• MalfunctionMay 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  UNABLE TO ASSEMBLE BROACHES WITH TRIAL NECKS. SURGICAL DELAY OF 5 MINUTES OCCURRED. ANOTHER INSTRUMENT WAS USED TO FINISH THE CASE. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491889 ↗
• MalfunctionFeb 17, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TRUNION OF BROACHES IS SCUFFED AND DOES NOT ALLOW MATING OF TRIAL NECKS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549800 ↗
• MalfunctionFeb 17, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TRUNION OF BROACHES IS SCUFFED AND DOES NOT ALLOW MATING OF TRIAL NECKS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549799 ↗
• MalfunctionFeb 17, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TRUNION OF BROACHES IS SCUFFED AND DOES NOT ALLOW MATING OF TRIAL NECKS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549792 ↗
• MalfunctionFeb 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  UNABLE TO CONNECT BROACH TO TRIAL NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476598 ↗
• 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 13454153 ↗
• 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 13453973 ↗
• 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 12843563 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 2 CORAIL BROACHES AND 1 NECK SEGMENT DO NOT CONNECT TOGETHER TO FORM A TRAIL FOR A UNCEMENTED HIP REPLACEMENT. THIS WAS FOUND DURING SURGERY, THERE WAS NO DELAY IN SURGERY AS THEY HAD A SPARE SET TO HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802921 ↗