CORAIL L20416Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295258186), received between Nov 7, 2017 and Jun 17, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE SIZE 16 BROACH DAMAGED DURING TRIALLING. THE TIP OF BROACH WAS HIT WITH A MALLET ACCIDENTALLY, DEFORMING THE TIP OF BROACH, RESULTING IN A TRIAL NECK NOT FITTING. THERE WAS A 3-4 MINUTES OF SURGICAL DELAY. A NEW TRAY OF BROACHES WAS OPENED, THE DAMAGES BROACH REMOVED AND REPLACED WITH ANOTHER OF THE SAME SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236204 ↗
• MalfunctionApr 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BROACHED USING CORAIL 8-16 CALCAR REAMED OVER A 16 WAS THEN UNABLE TO FIT THE NECK TO TRIAL AS REPORTED BY SCRUB NURSE. THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013466 ↗
• 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 TRAYSWHICH, ACCORDING TO THE HOSPITAL, REPRESENTS THAT THE MATERIAL IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454619 ↗
• 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 13454342 ↗
• MalfunctionDec 17, 2020Material Deformation; Illegible Information; Material Deformation; Illegible Information

  METAL CONNECTION OF BROACH WAS BENT. NOT USEABLE. BROACH NUMBER 16 CORAIL. NECK PIECE GETTING STUCK DUE TO ANGLE OF BENT METAL. DIFFICULT TO REMOVE. UNABLE TO TRIAL. NO ADVERSE EVENTS. NO SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028665 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE SURGEON PERFORMED A DIRECT ANTERIOR APPROACH TOTAL HIP REPLACEMENT ON THE LEFT SIDE WITH A PINNACLE CUP AND A CORAIL STEM. THE SURGEON BROACHED UP TO A SIZE 16 CORAIL BROACH. WHEN HE WANTED TO CALCAR PLANE, HE REALIZED THE CALCAR PLANER DID NOT SEAT FULLY OVER THE NUB ON THE BROACH. AFTER OPENING ANOTHER TRAY WITH ANOTHER CALCAR PLANER, IT WAS DETERMINED THAT SOMETHING MUST BE WRONG WITH THE SIZE 16 CORAIL BROACH.

  Patient problems: No Code Available

  MAUDE report 9741990 ↗
• 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 9310079 ↗
• 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 9310063 ↗
• 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 9310059 ↗
• 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 9310056 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  WON'T GO IN BROACH HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241353 ↗
• MalfunctionOct 17, 2019Material Twisted/Bent; Material Twisted/Bent

  THE POST ON A SIZE 16 CORAIL BROACH (L20416) HAS BECOME DEFORMED AS A RESULT OF CALCAR PLANING. NECK TRIALS ARE NO LONGER FITTING ON THE BROACH. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203792 ↗
• MalfunctionMay 30, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT AFTER OUR INSTRUMENTS CAME OUT OF THE WASH, IT WAS FOUND THAT THE 25MM DRILL BIT WAS STUCK IN THE DRILL GUIDE. AS WELL, THE FIRST LEVEL OF A CORAIL TRAY WAS DAMAGED IN STERILE PROCESSING. FINALLY, THE POST ON THE SIZE 16 CORAIL BROACH WAS BENT WHILE STERILE PROCESSING. SURGERY WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655159 ↗
• MalfunctionFeb 14, 2019Difficult to Insert; Scratched Material; Difficult to Insert; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENT OFFICE SETS HAD AN UNSPECIFIED MALFUNCTION. IT DID NOT AFFECT SURGERY OR PATIENT. IN-HOUSE ENGINEERING EVALUATION DETERMINED THE FOLLOWING: A FUNCTIONAL CHECK WITH A MATING BROACH HANDLE FOUND THE CIRCULAR SCRATCHING ON THE TAPER PREVENTED FROM SEATING CORRECTLY INTO THE BROACH HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339794 ↗
• MalfunctionJul 5, 2018Break; Break

  AFTER REMOVAL OF O-RING AS PER FSCA CORAIL (B)(4). THE TRIAL NECK AND THE TRIAL STEM ARE DISASSEMBLING/SEPARATING WITHOUT ANY FORCES. THIS DID NOT HAPPEN INTAOPERATIVELY, NO ADVERSE CONSEQUENCES FOR ANYBODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663864 ↗
• MalfunctionNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE (B)(6) BROACH HAS SLIGHT WEAR AND TEAR ON THE TRUNION. IT¿S CAUSING DIFFICULTY ACCEPTING FEMORAL NECK TRIAL AS WELL AS A CALCAR PLANER.

  Patient problems: No Information

  MAUDE report 7007194 ↗