CORAIL L20418Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295258193), received between Sep 22, 2017 and Mar 20, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE POST ON TOP OF THE SIZE 18 CORAIL BROACH BENT WHEN REMOVING THE BROACH HANDLE BEFORE TRIALING. THE SOFT TISSUES WERE PREVENTING THE BROACH HANDLE RELEASE FROM FULLY OPENING, SO GREATER FORCE THAN USUAL WAS NEEDED TO DISENGAGE THE HANDLE FROM THE BROACH. THERE WAS A FIVE-MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657377 ↗
• 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 13454562 ↗
• 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 13454354 ↗
• MalfunctionMar 5, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  PLEASE VERIFY IF THE INSTRUMENT USED DURING SURGERY? IF YES, WAS THERE SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? EVENT REPORTED AS WHILE IN HOSPITALS STERILE SERVICES UNIT, - NO SURGERY. PLEASE VERIFY WHAT IS MEANT BY "SMALL NOTCH"? WAS IT CRACKED OR SCRATCHED? THERE IS AN INDENTATION/INCISION ON THE BROACH LOCATED HALFWAY UP INSIDE CURVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422573 ↗
• 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 9312669 ↗
• 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 9312659 ↗
• 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 9312657 ↗
• 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 9312655 ↗
• InjuryDec 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE SURGEON BROACHED TO A SIZE 16 WHICH WAS TOO SMALL. THE SURGEON HAD NO OPTION BUT TO TRY THE 18 BROACH. THIS WAS UNREMARKABLE , HOWEVER WHEN THE SURGEON REDUCED THE FEMUR WITH THE STD NECK AND 32 +1 TRIAL HEAD IN SITU, THERE WAS AN AUDIBLE CRACK. DOE: (B)(6) 2017 ; SURGICAL DELAY OF 3 HOURS.

  Patient problems: Hip Fracture; Not Applicable

  MAUDE report 7098573 ↗
• MalfunctionSep 22, 2017Misconnection; Connection Problem; Misconnection; Connection Problem

  COMPLAINT DESCRIPTION: DER STATED THAT BROACHES CAN'T GET ONTO BROACH HANDLE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6886895 ↗