CORAIL L20415Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295258179), received between Dec 1, 2017 and Jul 3, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THA SURGERY WITH CORAIL PERFORMED WITH THE PRODUCT IN QUESTION. IN THE SURGERY DURING THE TRIAL, THE CORAIL AMT BROACH SIZE 15 AND THE CORAIL AMT NECK SEGMENT KLA 125 DEGREES DID NOT FIT TOGETHER PROPERLY, WHICH EXTENDED THE PROCEDURE TIME BY ABOUT 15 MINUTES. AFTER SEVERAL TRIALS, IT WAS CONFIRMED THAT THE PRODUCTS FIT TOGETHER, BUT THEY COULD NOT BE ATTACHED OR DETACHED SMOOTHLY. THE SURGEON CHECKED FIVE NECKS OF THE PRODUCTS IN QUESTION, AND FOUND THAT, LIKE THE ISSUE IN QUESTION, THEY COULD BE FITTED TOGETHER BUT COULD NOT BE REMOVED SMOOTHLY. IN ADDITION, SINCE THE ISSUE WAS NOT CONFIRMED WITH OTHER SIZE BROACHES AND NECK SEGMENTS, THERE MAY BE A PROBLEM WITH THE CORAIL AMT BROACH SIZE 15. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396500 ↗
• MalfunctionMay 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT TRIAL TRUNUON WAS WARPED AND NECK TRIALS WON'T SIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099607 ↗
• MalfunctionJul 3, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE PATIENT, UNDERWENT THE SURGERY VIA BHA, FOR FEMORAL NECK FRACTURE, FOR THE HIP JOINT WITH THE BROACH CORAIL NECK SEGMENT AND THE BROACH CORAIL. DURING SURGERY, WHEN PLACING THE NECK TRIAL, IT WAS HARDER THAN USUAL AND UNCOMFORTABLE TO PLACE. AFTER THE SURGERY, IT WAS CLEANED AND CHECKED. AND ALTHOUGH, IT WAS INSERTED SMOOTHLY, THE FEELING OF PLACEMENT WAS ROUGH. THERE MAY HAVE BEEN SOME FOREIGN OBJECT IN THE NECK TRIAL OR THERE MAY HAVE BEEN A SCRATCH ON THE MALE SIDE OF THE RASP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19665355 ↗
• MalfunctionJul 3, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA BHA FOR FEMORAL NECK FRACTURE FOR THE HIP JOINT WITH THE BROACH CORAIL NECK SEGMENT AND THE BROACH CORAIL. DURING SURGERY, WHEN PLACING THE NECK TRIAL, IT WAS HARDER THAN USUAL AND UNCOMFORTABLE TO PLACE. AFTER THE SURGERY, IT WAS CLEANED AND CHECKED, AND ALTHOUGH IT WAS INSERTED SMOOTHLY, THE FEELING OF PLACEMENT WAS ROUGH. THERE MAY HAVE BEEN SOME FOREIGN OBJECT IN THE NECK TRIAL, OR THERE MAY HAVE BEEN A SCRATCH ON THE MALE SIDE OF THE RASP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19665351 ↗
• MalfunctionJan 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH WAS NOT CONNECTING TO BROACH HANDLE PROPERLY AND GETTING JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516739 ↗
• MalfunctionNov 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH WILL NOT CONNECT TO THE HANDLE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, 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 18067498 ↗
• MalfunctionOct 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIAL WAS NOT PROPERLY ATTACHING TO THE BROACH. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884702 ↗
• MalfunctionJul 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: DURING A LOAN KIT INSPECTION, IT WAS FOUND THAT THE BROACH CORAIL DOES NOT SEAT FLAT IN NECK TRIALS, THE FIT IS TOO TIGHT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17399322 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488531 ↗
• 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 15886696 ↗
• 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 15886358 ↗
• MalfunctionOct 1, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  BHCRL1N WAS DELIVERED WITH A DEFECTIVE INSTRUMENT (L20415 - BROACH CORAIL AMT 15). THE BAR WAS BENT SO THAT BOTH THE BROACH HANDLE AND THE TRIAL NECKS COULDN'T BE CLICKED INTO PLACE. SALESFORCE CASE WAS OPENED TOWARDS THE PARTY WHO DEALS WITH LOANER SETS: CASE 14530591.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522604 ↗
• MalfunctionJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE BROACH STUCK ON THE KINCISE BROACH HANDLE, DIFFICULT TO REMOVE. DAMAGE TO THE CONNECTION OF BROACH. NO ISSUE WITH THE OTHER BROACHES ON THE TRAY SO CAN ELIMINATE THE BROACH HANDLE BEING DAMAGED. SURGICAL DELAY OF 5 MIN OCCURRED. NO ADVERSE AFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602308 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATED THE FOLLOWING: 1. QUANTITY RETURNED - ALL KITS RETURNED TO JOHNSON 2. CLEANING SOLUTION AND PROCESS - THESE DIRT ARE IDENTIFIED AT THE TIME OF OPENING THE MATERIAL FOR SURGERY. WE ARE WAITING FOR YOUR RESPONSE TO FORWARD A SOLUTION BECAUSE THE STAINS ON THE KITS DO NOT WASH OFF. WE JUST ADVISE YOU TO FOLLOW THE PRODUCT'S IFU. 3. CLARIFICATION ON WHAT PARTS WERE INVOLVED SINCE THE PHOTOS SHOW ONLY THE TRAYS WITH THE FOREIGN MATERIAL. - THE PARTS THAT WE REPORTED IN THE COMPLAINT (STEMS) THAT SHOW SOOT AND CAUSE THESE STAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454596 ↗
• 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 13454207 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS DON'T ATTACH TO BROACH HANDLE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310061 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS DON'T ATTACH TO BROACH HANDLE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310060 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS DON'T ATTACH TO BROACH HANDLE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310058 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS DON'T ATTACH TO BROACH HANDLE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310057 ↗
• MalfunctionOct 25, 2019Scratched Material; Scratched Material

  NECK TRIAL GETS STUCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241494 ↗
• MalfunctionOct 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORAIL BROACH SIZE 15 HAS A DEFECT ON THE MALE END OF THE PROXIMAL BROACH, ATTACHMENT OF NECK TRIAL WAS DIFFICULT TO GET ON AND OFF DUE TO THE DEFECT OF THE MALE END OF THE BROACH ATTACHMENT. T-HANDLE WAS DAMAGED AND BROKEN DURING THE REMOVAL OF ACETABULAR REAMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224385 ↗
• MalfunctionSep 11, 2019Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  THE NECK TRIAL WAS DIFFICULT TO PUT ON THE BROACH TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992195 ↗
• MalfunctionMay 2, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT AT THE ROD PORTION OF THE NECK OF THE COLAIL BROACH #15 (P/N L20415) WAS BROKEN OR DEFORMED WHEN THE SURGEON USED THE CALCAR REAMER SMALL DURING THE SURGERY ON (B)(6) 2019, SO THE SURGEON COULD NOT INSERT THE NECK TRIAL. THE SURGEON ATTEMPTED EXPLANTING THE BROACH HOWEVER THE BROACH HANDLE WAS NOT ABLE TO ATTACH, SO THE SURGEON FORCIBLY STRUCK THE BROACH HANDLE IN AND CONNECTED AND EXPLANTED THE BROACH. THE SURGEON DID A TRIAL TEST WITH THE BROACH #14 AND CONFIRMED THERE WAS NO PROBLEM BY THE X-RAY, IMPLANTED THE STEM #15. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8573831 ↗
• MalfunctionApr 8, 2019Failure to Advance; Device-Device Incompatibility; Scratched Material; Failure to Advance; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE THREADS ON DURALOC CUP HANDLE ARE BENT. NECK TRIALS WILL NOT SEAT ON CORAIL BROACH. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491872 ↗
• MalfunctionFeb 7, 2019Fitting Problem; Scratched Material; Fitting Problem; Scratched Material

  IT WAS REPORTED THAT THE NECK OF THE BROACH WAS NOT ALLOWING TRIAL TO SEAT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315657 ↗