CORAIL 9522-11-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 210 adverse event reports that list this exact device (DI 10603295230663), received between Jul 21, 2017 and Sep 25, 2026 — classified as 2 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (74 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 210 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility; Unintended Movement

  1 of the 2 brooach handles for Corail was loose. The user tried sz 8/10 up 14/16 broaches and the handle would not hold the broach, therefore it was not usable. The user used the only one that was functional. There was a slight delay. Was there any reported patient or user harm? No

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897214 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE CORAIL BROACH HANDLE WAS VERY LOOSE WHEN HOLDING THE MODULAR BOX OSTEOTOME, THOUGH IT HELD BROACHES ADEQUATELY. THE EVENT OCCURRED INTRA-OPERATIVELY, WITH NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137878 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT TWO (2) CORAIL BROACH HANDLE ARE BROKEN. THERE WAS NO ADVERSE PATIENT OUTCOME. IT HAPPENED DURING LAYUP RATHER THAN SURGERY, SO SURGICAL TIME ETC WAS NOT AFFECTED. NO FURTHER ACTION REQUIRED. HOSPITAL BELIEVE IT¿S DUE TO WEAR AND TEAR AS INSTRUMENTS ARE VERY OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701325 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT TWO (2) CORAIL BROACH HANDLE ARE BROKEN. THERE WAS NO ADVERSE PATIENT OUTCOME. IT HAPPENED DURING LAYUP RATHER THAN SURGERY SO SURGICAL TIME ETC WAS NOT AFFECTED. NO FURTHER ACTION REQUIRED, HOSPITAL BELIEVE IT¿S DUE TO WEAR AND TEAR AS INSTRUMENTS ARE VERY OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701293 ↗
• MalfunctionDec 16, 2025Break; Structural Problem; Break; Structural Problem

  IT WAS REPORTED THAT THE BROACH HANDLE IS BROKEN. A LATCH NO LONGER LOCKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822430 ↗
• MalfunctionJun 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE UNIVERSAL CURVED BROACH HANDLE WAS NO LONGER GRIPPING THE CORAIL BROACHES. THERE WAS NO PROCEDURE INVOLVEMENT. IT WAS THOUGHT THAT THE DAMAGE WAS DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306742 ↗
• MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE WAS NOT LOCKING ON. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763340 ↗
• MalfunctionApr 1, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BROACH HANDLE WAS WORN; THE HANDLE LOCK IS NOW LOOSE. NO PATIENT AFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738532 ↗
• MalfunctionFeb 20, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE CORIAL BROACH HANDLE IS BROKEN. THE HANDLE DOES NOT LATCH CLOSED AND STAYS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423331 ↗
• MalfunctionDec 30, 2024Structural Problem; Difficult to Open or Close; Illegible Information; Structural Problem; Difficult to Open or Close; Illegible Information

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE LOCKING MECHANISM ON THE BROACH HANDLE WOULDN'T CLOSE. THE LEVER OPENS UNINTENTIONALLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035942 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT INTERMEDIATE PROSTHESIS ON (B)(6) 2024. DURING THE PROCEDURE, SIZE 8 AND 9 GRATERS DID NOT FIT PROPERLY ON THE CURVED HANDLE AND MOVE. USE OF A SECOND DEVICE WHICH WAS PRESENT IN THE ANCILLARY. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918226 ↗
• MalfunctionDec 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT HARM REPORTED WITH THE RETURNED DEVICE. DURING A VISUAL EXAMINATION PERFORMED ON (B)(6) 2024 A CONDITION OF LOOSENING WAS FOUND.

  Patient problems: Insufficient Information

  MAUDE report 20918115 ↗
• MalfunctionNov 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735737 ↗
• MalfunctionNov 19, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT OLD BLOOD OR DIRT STAYS IN THE BROACH HANDLE EVEN AFTER STERILIZATION AND COULD NOT BE CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726180 ↗
• MalfunctionNov 19, 2024Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? THE HITTING FACE IS SMALL, AND THE RISK OF HITTING THE HANDLE IS HIGH. CAUSES DAMAGE ON THE HANDLE. 2. PLEASE CONFIRM HOW MANY OCCURRENCES OF THIS FAILURE OCCURRED WITH REGARD TO THE CURVED BROACH HANDLES. WE HAVE A GOOD NUMBER OF DEVICES WITH THIS PROBLEM. 3. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES FOR THE PATIENT, BUT FOR THE SURGEON AND NURSE USING THE INSTRUMENT. SMALL METAL PIECES TEARING HOLES IN THE GLOVES.

  Patient problems: Insufficient Information

  MAUDE report 20722311 ↗
• MalfunctionNov 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED. THERE WAS NO SURGICAL DELAY. THIS INSTRUMENT HAS BEEN IN THE HOSPITAL SINCE (B)(6). THE DAMAGE CAUSES SMALL SHARP PIECES TEARING THE GLOVES. THIS HAPPENED AFTER ONLY 3-4 MONTHS OF USE. IT WAS REPORTED THAT MORE DAMAGES WERE BEING SEEN ON THE INSTRUMENTS THAN WERE SEEN PREVIOUSLY WITH FORMER INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 20706413 ↗
• MalfunctionNov 14, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE THREAD SNAPPED OFF CLEAN AND THE REMAINING THREAD WAS INSIDE THE CORAIL BROACH HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685261 ↗
• MalfunctionOct 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS NOTED THAT THE BROACH HANDLE NOT LOCKING OFF SECURELY. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402712 ↗
• MalfunctionOct 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2024. DAMAGED SIZE 15 BROACH AND BROACH HANDLE DURING SURGERY. TRUNION ATTACHMENT OF SIZE 15 BROACH BENT, AND BROACH HANDLE NOT LOCKING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388533 ↗
• MalfunctionSep 25, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  BROACH HANDLE NOT LOCKING DUE TO VERY LOOSE MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300119 ↗
• MalfunctionAug 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  CORAIL BROACH HANDLE IS NOT STAYING CLOSED IN ORDER TO KEEP THE BROACH ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981208 ↗
• MalfunctionAug 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE IS A SLIGHT GAP BETWEEN RASP HOLDER AND RASP, MAKING IT UNUSABLE.PROCEDURE EXTENDED BY 10 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980710 ↗
• MalfunctionJul 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CORAIL BROACH HANDLE DOESN¿T BLOCK THE RASP. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781904 ↗
• MalfunctionApr 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE CORAIL HANDLE IS NOT HOLDING THE REAMER REPLACEMENT/BROACHES. CORAIL HANDLE IS BROKEN. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162783 ↗
• MalfunctionMar 15, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED THAT BROACH HANDLES ARE DAMAGED AND UNABLE TO BE STERILIZED. BOTH HANDLES ARE VERY OLD AND ARE DUE FOR REPLACEMENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, 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 18913411 ↗