CORAIL L20408Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295258100), received between Mar 23, 2018 and Sep 10, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026No Apparent Adverse Event

  It was reported that the broach had been introduced into the femoral canal, and an osteotomy of the femur was required at a level below the tip of the broach, however, since the broach was inside the femur, its tip could not be seen from the outside, and when the surgeon used the saw, he ended up scoring the edge of the broach's tip. No patient or user harm and no significant delay were reported.

  Patient problems: Bone Notching

  MAUDE report 50715639 ↗
• MalfunctionMar 26, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT ITEM DAMAGED AS , THE NECK SEGMENTS WILL NOT ENGAGE WITH THE NECK SEGMENTS/BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979023 ↗
• 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 18431247 ↗
• MalfunctionMay 3, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE POST ON THE BROACH WAS DEFORMED AND WOULD NOT SMOOTHLY ACCEPT THE NECK TRIALS. SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859378 ↗
• 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 16434911 ↗
• 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 15886902 ↗
• 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 15886563 ↗
• MalfunctionJul 12, 2022Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  IT WAS REPORTED THAT BROACH WAS DIFFICULT TO REMOVE FROM HANDLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986199 ↗
• 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 (SEE ATTACHED PHOTOS) WHICH, ACCORDING TO THE HOSPITAL, REPRESENTS THAT THE MATERIAL IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454347 ↗
• 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 13453964 ↗
• 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 12843574 ↗
• MalfunctionOct 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH WON'T FIT ON THE BROACH HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567802 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS NEED REPLACEMENT DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274035 ↗
• MalfunctionApr 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING A THA A CORAIL SIZE 8 BROACH GOT STUCK WHEN REMOVAL WAS ATTEMPTED FROM THE BROACH HANDLE. MALLET STRIKES WERE REQUIRED TO REMOVE THE BROACH FROM THE HANDLE, DELAYING THE PROCEDURE BY 30 SECONDS. NO FRAGMENTS WERE GENERATED. SUBSEQUENT BROACHES WORKED NORMALLY WITH THE BROACH HANDLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633307 ↗
• MalfunctionDec 10, 2020Break; Break

  TRUNION BROKE OFF SIZE 8 BROACH WHILE IMPACTING INTO FEMUR WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 15. ACTION TAKEN WHEN EVENT OCCURRED? FLEXIBLE OSTEOTOMES AND SLAP HAMMER TO REMOVE FROM FEMUR. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. 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: Insufficient Information

  MAUDE report 10984969 ↗
• MalfunctionDec 3, 2019Dull, Blunt; Dull, Blunt

  BROACHES HAVE LOST THEIR ¿RELATIVE¿ SHARPNESS THROUGHOUT THE SIZE RANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404777 ↗
• InjuryOct 31, 2019Inadequacy of Device Shape and/or Size; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Device-Device Incompatibility

  WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY- 1 HOUR. WHILE BROACHING A FEMUR WITH BROACH SIZE 8, A FRACTURE APPEARED IN THE CALCAR.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 9261006 ↗
• MalfunctionOct 9, 2019Dull, Blunt; Dull, Blunt

  THE BROACHES HAVE LOST THEIR ¿RELATIVE¿ SHARPNESS THROUGHOUT THE SIZE RANGE AND WOULD LIKE THEM TESTING SIZING AND TOLERANCE ¿ THESE BROACHES ARE RELATIVELY NEW BEING APPROX. 12 MONTHS OLD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9172726 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 8 CORAIL BROACH WILL NOT ATTACH TO THE ANTERIOR APPROACH KINCISE BROACH ADAPTER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672092 ↗
• MalfunctionMay 17, 2019Device Damaged Prior to Use; Device-Device Incompatibility; Material Deformation; Naturally Worn; Device Damaged Prior to Use; Device-Device Incompatibility; Material Deformation; Naturally Worn

  2 DAMAGED CORAIL BROACHES THAT WOULD NOT ATTACH TO THE BROACH HANDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8620366 ↗
• MalfunctionMay 14, 2019Break; Device-Device Incompatibility; Physical Resistance/Sticking; Break; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SIZE 8 CORAIL BROACH AND TRI LOCK STARTER BROACH WOULD GET STUCK IN THE KINCISE BROACH HANDLE BUT NOT IN THE STANDARD BROACH HANDLE. I BELIEVE THE FIT MIGHT BE TIGHTER IN THE IN THE KINCISE HANDLE IF THERE IS A SMALL DEFECT ON THE ATTACHMENT POINT OF THE BROACH. IT DIDN'T AFFECT THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609717 ↗
• MalfunctionJan 22, 2019Fitting Problem; Fitting Problem

  THE BROACHES ARE OUT OF TOLERANCE, NOT FITTING ON THE NECK TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266440 ↗
• MalfunctionDec 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE TRIAL NECK AND THE TRIAL STEM ARE DISASSEMBLING/SEPARATING WITHOUT ANY FORCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189156 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BROACHING OF THE FEMUR IT CRACKED. NO SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7365130 ↗