CORAIL L20413Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295258155), received between Jul 21, 2017 and May 5, 2026 — classified as 2 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (35 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH IS STICKING TO NECKS MAKING THEM DIFFICULT TO CONNECT TO BROACH WHEN TRAILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082384 ↗
• MalfunctionAug 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE CORAIL SIZE 13 BROACH WOULD NOT SIT NECK TRIALS DOWN ON THE TRUNION WHEN TRIALLING. THEY TRIED ALL NECK TRIALS AND NONE SAT, BUT ALL NECK TRIALS SAT FLUSH WITH ALL OTHER BROACHES. THE BROACH SANK FURTHER AND THEN UPSIZED TO A SZ14 THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894402 ↗
• MalfunctionAug 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WARPED METAL ON SIZE 13 BROACH NECK ATTACHMENT. MODULAR NECK TRIALS GETTING STUCK ON BROACH. VERY STIFF AND DIFFICULT TO REMOVE NECK SEGMENT. TRIALED DIFFERENT NECK SEGMENTS AND ALL WERE DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816529 ↗
• MalfunctionOct 4, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE DEVICES SUMMIT CALCAR PLANER-LARGE AND BROACH CORAIL AMT 13 HAD SUSTAINED SIGNIFICANT DAMAGE IN THE FORM OF GOUGES, SCRATCHES AND BURRED EDGES. THESE TWO COMPLAINED ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372306 ↗
• MalfunctionSep 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211692 ↗
• MalfunctionAug 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE BROACH WOULD NOT EASILY ATTACH TO BROACH HANDLE. THE NECK TRIAL WOULD NOT SEAT ONTO THIS SAME BROACH. IT ALSO STATED THAT THERE WERE NO PATIENT CONSEQUENCES AND THERE WAS A SHORT DELAY, ROUGHLY 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937454 ↗
• MalfunctionMar 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE BROACH CORAIL AMT 13 IS BENT, DOES NOT FIT INTO BROACH HANDLE. 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 18969453 ↗
• MalfunctionMar 13, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE BROACH IS WORN AND SHEDS METAL PARTICLES FROM WHERE THE BROACH HANDLE IS ATTACHED. 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? NO. IS LITIGATION INDICATED OR PENDING? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893080 ↗
• MalfunctionNov 14, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CORAIL SIZE 13 BROACH POST WAS STRIPPED DURING CALCAR REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131364 ↗
• MalfunctionNov 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK SEGMENTS WOULD NOT FIT ON CORAIL BROACH SIZE 13. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055507 ↗
• MalfunctionOct 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECKS WOULD NOT GO ON THE BROACH AND THE BROACH WAS STUCK ON THE BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949433 ↗
• MalfunctionAug 23, 2023Corroded; Corroded

  IT WAS REPORTED THAT DEVICE HAS RUST STAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608288 ↗
• MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TRIAL STEM NOT ATTACHING TO TRIAL NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487736 ↗
• 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 16364494 ↗
• MalfunctionJan 24, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  CORAIL SIZE 13 BROACH TRUNNION/POST DAMAGED. UNABLE TO SEAT NECK TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232056 ↗
• 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 15886819 ↗
• 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 15886356 ↗
• MalfunctionSep 9, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A CORAIL PINNACLE CASE TODAY WE WERE HAVING TROUBLE ATTACHING THE BROACH HANDLE AND KLA NECK TRIAL TO THE SIZE 13 BROACH WHEN IT WAS IN SITU. AFTER THE CASE I GOT HANDS ON WITH THE BROACH AND COULD FEEL THAT THE POST AT THE TOP OF THE BROACH WAS CATCHING IN THE BROACH (BUT NONE OF THE OTHER SIZES WERE) AND I WAS ALSO STRUGGLING TO FULLY SEAT THE KLA NECK TRIAL (BUT I DIDN'T HAVE THIS ISSUE WITH THE OTHER SIZES). AFTER LOOKING AT THE SIZE 13 BROACH AGAIN IT LOOKED LIKE THE POST AT THE TOP WAS BENT SLIGHTLY.

  Patient problems: Insufficient Information

  MAUDE report 15390534 ↗
• 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 14492272 ↗
• MalfunctionMay 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACHES WERE NOT CONNECTING PROPERLY TO THE BROACH HANDLE. THIS ONLY HAPPENED WITH BROACH 13 & 14, OTHER SIZES OK. THERE WAS A TEN MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 14356540 ↗
• MalfunctionMar 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  NECK SEGMENT OF BROACH DAMAGED. UNABLE TO TRIAL AS NECK SEGMENT WOULD NOT ATTACH. TRIALED WITH A BROACH SIZE SMALLER. OPERATION CONTINUED AS PLANNED. THERE WAS A THREE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801672 ↗
• MalfunctionMar 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE NECK SEGMENT CANNOT BE SECURED ON THE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635602 ↗
• MalfunctionMar 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE NECK SEGMENT IS DIFFICULT TO SECURE ON MOST BROACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635514 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454502 ↗
• MalfunctionFeb 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454170 ↗