NA 2178-63-181Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295096382), received between Jul 27, 2017 and Dec 22, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ALL REAMERS WERE LOOSE ON THE ADAPTERS AND SPUN FREELY. ADAPTER WOULD SPIN FREELY WHEN ATTACHED TO REAMERS OR ANY OTHER ATTACHMENT. T-HANDLE WAS ALSO LOOSE. ATTACHMENT POINT SEEMS TO BE WEAK AND CAME FREE AT FIRST SIGN OF RESISTANCE. NO PIECES WAS BROKEN OFF IN PATIENT. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY TIME WAS EXTENDED BY APPROXIMATELY 30 AS A RESULT OF DEPUY INSTRUMENTS NOT FUNCTIONING PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 11057619 ↗
• MalfunctionDec 21, 2020Failure to Cut; Material Twisted/Bent; Naturally Worn; Failure to Cut; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046296 ↗
• MalfunctionFeb 12, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMERS WERE STRIPPED AND DID NOT HOLD ONTO THE CHUCK. NO SURGICAL DELAY HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330806 ↗
• MalfunctionDec 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE ROUNDED OUT AND WOULD NOT STAY LOCKED IN THE HUDSON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124403 ↗
• MalfunctionMar 21, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS REAMING THE TIBIA AND THE MBT REVISION REAMERS WERE SPINNING INSIDE THE MODIFIED HUDSON ADAPTER CONNECTION AND T-HANDLE CONNECTION. THIS REQUIRED HAVING TO USE SEVERAL DIFFERENT HUDSON ADAPTERS TO COMPLETE THE REAMING. AS A RESULT, THE REAMERS AND ADAPTERS ARE NO LONGER FUNCTIONING CORRECTLY. THERE WERE NO PIECES BROKEN OFF OF ANY OF THE INSTRUMENTS AND NO ADVERSE AFFECT TO THE PATIENT AND THE SURGEON DOES NOT WANT TO BE CONTACTED. THERE IS NO FURTHER INFORMATION AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7357303 ↗
• MalfunctionJul 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION REAMER FAILED TO STAY ATTACHED TO REAMER HANDLES OR HUDSON END. REAMER APPEAR TO BE ROUND OFF AND WILL NOT TURN WHEN ENGAGED WITH POWER REAMER OR WITH HAND REAMER. TIPS APPEAR TO BE WORN.

  Patient problems: No Information

  MAUDE report 6746554 ↗