CORAIL L20412Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 10603295258148), received between Jul 21, 2017 and May 22, 2026 — classified as 6 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (45 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 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Material Deformation

  IT WAS REPORTED DURING CALCAR REAMING, THE 12 BROACH TRUYEN GOT BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254612 ↗
• InjuryMar 24, 2026Device-Device Incompatibility; Material Deformation; Scratched Material

  ADDITIONAL INFORMATION RECEIVED: WHAT KIND OF DAMAGE WAS ON THE POST OF THE BROACHES. WERE THEY BENT/DEFORMED OR SCRATCHED? THE POSTS ON THE BROACHES HAD BECOME DEFORMED AND SCRATCHED.

  Patient problems: Limb Fracture

  MAUDE report 24680314 ↗
• MalfunctionJun 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HAS WORN AWAY NEAR WHERE NECK TRIAL SITS SO IT IS LOOSE WHEN NECK TRIAL SITS ON BROACH. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161566 ↗
• MalfunctionMar 4, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. AFTER ALL THE FEMORAL PREP WAS DONE, CHISEL PREP COMMENCED. WHEN IMPACTING OUT, THE CHISEL GOT STUCK AND SNAPPED INSIDE THE FEMORAL CUTTING BLOCK. THE BROACH CORAIL AMT 12 WAS BROKEN. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517790 ↗
• MalfunctionAug 9, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE CORAIL BROACH HAS A DAMAGE TRUNNION AND ALSO THE CALCAR REAMER THAT WAS USED TO REAM THE CALCAR SHOULD BE REPLACED. THE CALCAR IS NOT SHARP, THEREFORE PROBABLY THE SURGEON PUT EXTRA EFFORT AND DAMAGED BOTH OF THE INSTRUMENTS. NO PATIENT HARM NO DELAYS INSTRUMENTS ARE NOT BROKEN INTO SMALLER PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947851 ↗
• InjuryJul 18, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? -MINIMAL PATIENT CONSEQUENCE IN THE SENSE THAT WE NEEDED TO REMOVE SOME EXTRA BONE AROUND THE FEMORAL CALCAR IN ORDER TO GET GRIP ON THE BROACH THAT WAS STUCK IN THE CANAL. PATIENT HAS NO FUNCTIONAL COMPLICATIONS FROM THIS. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? -TIME ADDED TO THE SURGERY WAS ABOUT 10MINS

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 19773893 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT A CORAIL BROACH NECK BROKE DURING SURGERY. ALL PARTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 19018232 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF THE BROACH DURING BROACHING. SURGERY TIME EXTENDED APPROXIMATELY 2 HOURS AS A DIRECT RESULT OF INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920207 ↗
• MalfunctionJan 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DUE TO REPEATED USE, THE BROACH AND NECK SEGMENTS WILL NOT ASSEMBLE 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 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 18570326 ↗
• 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 18431679 ↗
• MalfunctionOct 19, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BROACH WAS BROKEN. WHERE / WHEN DID THE EVENT OCCUR? INTRA-OP. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? NO. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED? YES. IS LITIGATION INDICATED OR PENDING? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965157 ↗
• MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORAIL RASP WAS NOT FITTING ON TO THE BROACH HANDLE ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381991 ↗
• MalfunctionJul 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIALS WOULD NOT FIT DOWN ON THE BROACH.THE CALCAR PLANE WAS ALSO REPORTED TO BE BLUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327265 ↗
• MalfunctionJun 6, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CORAIL BROACH SIZE 12 COULD NOT BE TRIALED DUE TO MALE ATTACHMENT BEING WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070377 ↗
• MalfunctionMay 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRUNNION WOULDN¿T FIT THE TRIAL NECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955295 ↗
• MalfunctionApr 26, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHILE USING THE CORAIL SYSTEM, THE SURGEON USED BROACH SIZE 12, AND THE BROACH DID NOT ATTACH TO THE HANDLE WELL. HE BROACH THE FEMUR AND WENT TO REMOVE THE BROACH TO THE NEXT SIZE, AND THE BROACH WAS STUCK TO THE HANDLE AND HAD TO BE MANIPULATED OFF THE HANDLE WITH A COBB. THE HANDLE IS INTACT AND WORKS WITH ALL OTHER BROACHES, BUT THE SIZE 12 BROACH DOES NOT FIT WELL ON ANY OF THE OTHER ALTERNATIVE HANDLES. BELIEVE THE BROACH POST IS BENT OR DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814358 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 12 BROACH HAD A DENT IN IT AT THE TOP PART WHICH CONNECTS TO THE NECK TRIALS AND WOULDN¿T ALLOW THE NECKS TO FULLY SEAT DOWN ON IT. THIS MEANS A PROPER TRIAL IS UNABLE TO BE CARRIED OUT WITH THIS SIZE.

  Patient problems: Insufficient Information

  MAUDE report 16486121 ↗
• 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 16434922 ↗
• MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE ATRAUMATIC BROACHES OF THE FEMUR HAVE AN ECCENTRIC FIT, WHICH MAKES IT DIFFICULT TO FIT IN THE WRIST AND TRIAL NECKS DURING SURGERY. THERE WERE NO INTERCURRENCES DURING THE SURGERY, NOR FOR THE PATIENT, BUT IT MAKES IT DIFFICULT TO PERFORM THE TECHNIQUE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364492 ↗
• MalfunctionFeb 1, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE SIZE 12 CORAIL BROACH - DAMAGED TRUNNION/POST. UNABLE TO SEAT NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278445 ↗
• MalfunctionDec 29, 2022Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE NECK TRIAL WOULD NOT GO ONTO SIZE 12 BROACH. APPEARS THE POST OF THE BROACH HAS BEEN DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067371 ↗
• MalfunctionDec 8, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE BROACH IS WORN AND CAN¿T ATTACH TO BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939617 ↗
• 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 15886797 ↗
• 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 15886438 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE BROACH WOULD NOT CONNECT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835425 ↗