CORAIL 952210500FRecalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10603295230656), received between Jun 27, 2017 and Mar 10, 2026 — classified as 157 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (95 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 157 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT THE HANDLE BROKE WHILE IMPACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560385 ↗
• MalfunctionJul 30, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BROACH HANDLE WAS LOOSE. IT EASILY CAN COME UNDONE AND DETACHES THE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665099 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE CORAIL BORACH HANDLE BECOMING LOSE AND NOT HOLDING ON TO THE BROACHES CORRECTLY. SECOND TRAY WAS OPENED TO FINISHED OPERATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578769 ↗
• MalfunctionJul 21, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE STRAIGHT BROACH HANDLE DID NOT CLOSE PROPERLY AND THE MODULAR BOX OSTEOTOME WAS DULL AND THE EDGES WERE ROLLED. ITEMS WERE DISCARDED AS THEY WERE UNFIT FOR USE ON A PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555564 ↗
• MalfunctionJul 21, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE STRAIGHT BROACH HANDLE DID NOT CLOSE PROPERLY AND THE MODULAR BOX OSTEOTOME WAS DULL AND THE EDGES WERE ROLLED. ITEMS WERE DISCARDED AS THEY WERE UNFIT FOR USE ON A PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555139 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE BROACH HANDLE NO LONGER CLOSED, IT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468873 ↗
• MalfunctionJun 27, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BROACH HANDLE FROM CORAIL HIP SET IS BROKEN. LATCH NO LONGER WORKS TO RETAIN BROACH ONTO HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346361 ↗
• MalfunctionJun 9, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BROACH HANDLE WAS LOOSE AND NO LONGER GRIPS THE BROACH. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167874 ↗
• MalfunctionMay 29, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT USER WAS GOING THROUGH SOME OF THEIR OLDER INSTRUMENT SETS TODAY AND FOUND TWO CORAIL STRAIGHT BROACH HANDLES THAT HAD A FAILED LOCKING MECHANISM AND NEED TO BE REPLACED. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107846 ↗
• MalfunctionMay 29, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT USER WAS GOING THROUGH SOME OF THEIR OLDER INSTRUMENT SETS TODAY AND FOUND TWO CORAIL STRAIGHT BROACH HANDLES THAT HAD A FAILED LOCKING MECHANISM AND NEED TO BE REPLACED. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107844 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077559 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077536 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077520 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077515 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077493 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077467 ↗
• MalfunctionMay 8, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE LOCKING MECHANISM HAD LOOSENED, CAUSING HANDLE TO BE LAX AROUND THE BRICK. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21986357 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894084 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894054 ↗
• MalfunctionJan 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219412 ↗
• MalfunctionJan 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219407 ↗
• MalfunctionJan 23, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219309 ↗
• MalfunctionJan 23, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219306 ↗
• MalfunctionJan 23, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219305 ↗
• MalfunctionJan 23, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, STAFF IDENTIFIED THAT THE WHITE PLASTIC HANDLE OF COMPLAINED ITEMS WERE CRACKED. IN ADDITION, THE SECURE CLASP FUNCTION OF COMPLAINED ITEMS HAD WEAKENED SIGNIFICANTLY AND NO LONGER ADEQUATELY CLASPED A BROACH SECURELY. THESE ITEMS WERE DEMAND TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219303 ↗