CORAIL L20411Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10603295258131), received between Jun 23, 2017 and Mar 24, 2026 — classified as 3 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (52 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device-Device Incompatibility; Material Deformation; Scratched Material

  PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026. THE CALCAR PLANER HAD DAMAGED BOTH THE 11 AND 12 BROACHES CONNECTION POINTS. THE SURGEON HADN¿T REALIZED THIS UNTIL THE NECK TRIAL THEN GOT STUCK ON THE 12 BROACH MAKING THE TRIAL CONSTRUCT VERY DIFFICULT TO REMOVE. NECK TRIAL WILL NOT CONNECT ONTO 11 AND 12 BROACHES DUE THEIR DAMAGE NOW BUT NECK STILL WORKS ON THE OTHER SIZES. THE PATIENT SUFFERED A CRACK TO THE CALCAR WHILST TRYING TO GET THE STUCK TRIAL OUT AND NEEDED A CABLE FOR REINFORCEMENT. ONCE STUCK BROACH CAME OUT THE IMPLANTS WERE IMPLANTED. PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information; Limb Fracture

  MAUDE report 24673961 ↗
• MalfunctionFeb 24, 2026Break

  ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CONFIRM THAT THE BROACH HAS BEEN COMPLETELY REMOVED FROM THE PATIENT? - YES IT WAS REMOVED. IT WAS JUST A NORMAL WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429165 ↗
• MalfunctionAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  DURING A PROCEDURE, THE BROACH COULD NOT BE FASTENED TO THE BROACH HANDLE. A SAME LIKE DEVICE WAS AVAILABLE FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843622 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT THE TOP OF A CORAIL RASP WAS BROKEN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566175 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE RASPS TO CONNECT TO THE INTRODUCER HAD SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859671 ↗
• MalfunctionFeb 13, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE BROACH WAS NOT FITTING ON THE HANDLE CORRECTLY, IT WAS DAMAGED AT THE CONNECTOR. THERE WAS NO PATIENT IMPACT. A SECOND TRAY WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374749 ↗
• MalfunctionDec 11, 2024Scratched Material; Scratched Material

  IT WAS REPORTED ON AN UNKNOWN DATE THE BROACH(S) WERE DAMAGED. SURGEON OPENED A 2ND SET WHEN THE BROACH IN THE FIRST SET WAS DAMAGED, BUT THE SAME BROACH IN THE 2ND SET WAS SIMILARLY DAMAGED, SO HE PERSEVERED WITH THE 2ND SET. THE SIZE 11 CORAIL BROACH WAS DAMAGED ON THE CONNECTION TAPER AND THE SURGEON HAD DIFFICULTY CONNECTING IT TO THE BROACH HANDLE. OTHER BROACHES IN THE SET CONNECTED EASILY TO THE BROACH HANDLE. A 2ND SET WAS OPENED AND THE SIZE 11 BROACH HAD SIMILAR DAMAGE, SO THE SURGEON DECIDED TO PERSEVERE WITH IT RATHER THAN OPEN A 3RD SET. THE SURGEON STATED THAT THE DAMAGED TO THE CONNECTION TAPER LOOKED TO HAVE BEEN CAUSED BY THE CALCAR REAMER DURING A PREVIOUS CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905078 ↗
• MalfunctionDec 11, 2024Scratched Material; Scratched Material

  IT WAS REPORTED ON AN UNKNOWN DATE THE BROACH(S) WERE DAMAGED. SURGEON OPENED A 2ND SET WHEN THE BROACH IN THE FIRST SET WAS DAMAGED, BUT THE SAME BROACH IN THE 2ND SET WAS SIMILARLY DAMAGED, SO HE PERSEVERED WITH THE 2ND SET. THE SIZE 11 CORAIL BROACH WAS DAMAGED ON THE CONNECTION TAPER AND THE SURGEON HAD DIFFICULTY CONNECTING IT TO THE BROACH HANDLE. OTHER BROACHES IN THE SET CONNECTED EASILY TO THE BROACH HANDLE. A 2ND SET WAS OPENED AND THE SIZE 11 BROACH HAD SIMILAR DAMAGE, SO THE SURGEON DECIDED TO PERSEVERE WITH IT RATHER THAN OPEN A 3RD SET. THE SURGEON STATED THAT THE DAMAGED TO THE CONNECTION TAPER LOOKED TO HAVE BEEN CAUSED BY THE CALCAR REAMER DURING A PREVIOUS CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904435 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SIZE 11 BROACH WILL NOT ACCEPT ANY TRIAL NECK. LOOKS TO BE SLIGHTLY BENT. THE CUP IMPACTOR WILL NOT STAY LOCKED. THE TRIAL LINER IS CRACKED. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19959566 ↗
• MalfunctionAug 12, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE 11 BROACH WOULD NOT ACCEPT ANY TRIAL NECK AND APPEARED TO BE SLIGHTLY BENT.

  Patient problems: Insufficient Information

  MAUDE report 19959480 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY SURGEON AND REGISTRAR THAT THEY WERE HAVING DIFFICULTY WITH ATTACHING THE STD 125 NECK TRIAL TO THE SIZE 11 BROACH. TOOK THE CONSTRUCT OUT AND WAS ABLE TO ATTACH, THEN RE SUNK BROACH AND WAS ABLE TO RUN FULL TRAIL WITH NO ISSUES. SURGEON NOTED THAT THE BROACH TRUNNION MAY BE BENT. COULDN'T VIEW THIS IN SURGERY. LIMITED IMPACT ON SURGICAL TIME (LESS THAN 10 MINS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728574 ↗
• MalfunctionApr 26, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  POST OF SIZE 11 CORAIL BROACH IS DAMAGED. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193603 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT CORAIL 11 BROACH IMPACTOR NECK IS STICKING TO BROACH HANDLE. NO DELAY IN SURGERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869953 ↗
• MalfunctionFeb 29, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  THE TRUNNION ON THE BROACH IS WORN OUT. UNABLE TO ENGAGE TRIAL NECK OPTIONS PROPERLY. IF OTHER, DESCRIBE NO PATIENT INVOLVEMENT, DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO PATIENT INVOLVEMENT, 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 18812796 ↗
• MalfunctionFeb 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER BROACHING, THE SURGEON ATTEMPTED TO TRIAL BUT NONE OF THE NECK TRIALS WOULD SMOOTHLY FIT ONTO THE SIZE 11 CORAIL BROACH. THE NECK TRIALS WOULD GET STUCK OR NOT PROPERLY SIT ON THE SIZE 11 BROACH. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748417 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WILL NOT ASSEMBLE TO HANDLE AS INTENDED. 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, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 18658541 ↗
• MalfunctionFeb 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH POST WOULD NOT ASSEMBLE WITH NECK TRIAL AS INTENDED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? 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 18651845 ↗
• 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 18431680 ↗
• MalfunctionDec 19, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE SIZE 11 CORAIL BROACH WAS RUFFED UP BY THE CALCAR PLANAR AND NOW WILL NOT CAPTURE INSIDE THE KINCISE BROACH ADAPTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356459 ↗
• MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS WERE NOTICED TO BE ARE BROKEN UPON INSPECTION. THE TOP BALL DOES NOT GO IN TO SLIDE ON THE TRIAL. THE BROACH DOES NOT LOCK IN ON THE HANDLE. THE DEVICE DOES NOT SLIDE INTO THE BROACH. THERE WAS A CRACK ON THE TIGHTENING WHEEL. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334721 ↗
• MalfunctionNov 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORAIL BROACH WOULD NOT ATTACH PROPERLY TO THE BROACH HANDLE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147445 ↗
• MalfunctionNov 2, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE FEMORAL BROACH DOES NOT FIT CORRECTLY INTO THE CORRESPONDING HANDLE OR INTO THE TEST NECKS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? THE SIZE OF THE BROACH HAS CHANGED., 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 HOSPITAL, DEVICE IN POSSESSION OF CLIENT, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057898 ↗
• MalfunctionSep 28, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE POST ON SIZE 11 CORAIL BROACH IS DAMAGED. UNABLE TO SEAT NECK TRIAL. LOAN SET, DAMAGED TAG ATTACHED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? - NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? - UNKNOWN, WERE FRAGMENTS GENERATED? - UNKNOWN, 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: - 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 17835300 ↗
• MalfunctionMay 9, 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 16898801 ↗
• 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 16434920 ↗