MULLER 2354-10-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295119821), received between Mar 22, 2019 and Aug 31, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521964 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079956 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079954 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079946 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079936 ↗
• 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 22077508 ↗
• 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 22077454 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024 THAT OUR CANAL FINDERS ARE NOT CONNECTING WITH THE HUDSON T-HANDLES. EVENT DID NOT HAPPY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20690073 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON NOVEMBER 5, 2024 THAT OUR CANAL FINDERS ARE NOT CONNECTING WITH THE HUDSON T-HANDLES. EVENT DID NOT HAPPY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689099 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. B. CAN YOU PLEASE CLARIFY WHAT YOU MEAN BY "DAMAGED"? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED, OR ANY DEVICE INTERACTION? WORN, BENT, AND SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550812 ↗
• MalfunctionOct 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT CANA AWLS WOULD NOT ATTACH TO T HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 20364024 ↗
• MalfunctionOct 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT CANA AWLS WOULD NOT ATTACH TO T HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 20363994 ↗
• MalfunctionSep 25, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CANAL FINDER WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305934 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE CANAL AWL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303073 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE CANAL AWL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303005 ↗
• MalfunctionMay 20, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS WERE NOT SHARP. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355117 ↗
• MalfunctionMay 20, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS WERE NOT SHARP. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355070 ↗
• MalfunctionMay 20, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS WERE NOT SHARP. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355062 ↗
• MalfunctionMay 20, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMERS WERE NOT SHARP. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354993 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE T-HANDLE AND AWL/CANAL FINDER WILL NOT COME APART. THE HOSPITAL HAS SENT IT DOWN TO BIO-MED AND IT STILL WON'T COME APART. THE HANDLE WAS ALMOST BRAND NEW AND EVERY TIME IT WAS USED IT DIDN'T CLICK IN PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605084 ↗
• MalfunctionOct 18, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961469 ↗
• MalfunctionMay 11, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT DUE TO WEAR AND TEAR, IT'S NOT HOLDING TO THE POWER TOOL ATTACHMENT. THIS HAPPENED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910213 ↗
• MalfunctionMay 8, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DEVICE IS DAMAGED DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886690 ↗
• MalfunctionFeb 21, 2023Break; Break

  STAFF HAVE INDICATED AN EXCEL T HANDLE REQUIRES REPLACEMENT DUE TO A CRACKED HANDLE. THIS IS FROM WEAR AND TEAR OVER TIME. THEY ALSO REQUIRE A REPLACEMENT CANAL MULLER REAMER AS IT HAS CHIPPED AND IS NO LONGER FUNCTIONAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408695 ↗
• MalfunctionDec 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  CAN¿T CONNECT THE TWO INSTRUMENTS BUT UNABLE TO ASSESS WHETHER IT¿S THE T HANDLE OR THE REAMER ITSELF AS T HANDLE IS STILL USABLE WITH A DIFFERENT REAMER AND STRAIGHT REAMER WORKS WITH A DIFFERENT T HANDLE. NO VISIBLE DAMAGE TO EITHER ITEM. NO DELAY TO SURGERY OR HARM TO PATIENT. IDENTIFIED IN SURGERY TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061976 ↗