NA 2178-63-179Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295096368), received between Jul 27, 2017 and Aug 27, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CONNECTION ON THE 19MM REAMER SEEMED STRIPPED DURING USE. THE T HANDLE RATHER THAN THE POWER ADAPTER WAS UTILIZED TO REMOVE. DELAY WAS LIKELY 15-30 SECONDS AND HAD NO NEGATIVE OUTCOME ON THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075768 ↗
• MalfunctionNov 17, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CONNECTION END OF THESE PARTS IS WORN AND NEEDS REPLACING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829256 ↗
• MalfunctionSep 28, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 19MM REAMER IS STRIPPED AND WON'T CONNECT TO THE T-HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540005 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825431 ↗
• MalfunctionJan 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO REAMERS FROM THE MBT REAMER SET ARE STARTING TO SHOW WEAR ON THE CONNECTION END. THE T-HANDLE AND MODIFIED HUDSON ADAPTER ARE ALSO SHOWING SIGNS OF ROUNDING OUT ON THE CONNECTION END. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247625 ↗
• MalfunctionJan 5, 2021Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT T HANDLE, CHUCKS, AND REAMERS ARE ALL DULL AND DO NOT STAY LOCKED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117533 ↗
• 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 11055425 ↗
• 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 11046286 ↗
• MalfunctionFeb 11, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695065 ↗
• MalfunctionMar 25, 2019Break; Material Deformation; Material Twisted/Bent; Naturally Worn; Break; Material Deformation; Material Twisted/Bent; Naturally Worn

  TOTAL KNEE REVISION. CASE WAS NOT EXPLANTING A DEPUY IMPLANT. WHILE REAMING, SOME OF THE REAMERS WERE BREAKING FREE FROM THE HUDSON ADAPTER WHERE THEY WERE NOT ABLE TO FULLY ENGAGE THE CORTICES. THERE WAS A FIVE MINUTE DELAY DUE TO DIFFICULTY REAMING. FLAGGED BROKEN INSTRUMENTS AND OPENED ANOTHER SET TO CONTINUE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. ONCE PROCESSED THROUGH SPD, MULTIPLE REAMERS (16,17,18,19,20,22) WERE NOTICED TO HAVE ROUNDED ENDS WHERE IT ATTACHED TO THE HUDSON ADAPTOR. IT WAS ALSO NOTICED THAT BOTH HUDSON ADAPTORS AND T-HANDLES HAVE WORN HUDSON ADAPTORS.

  Patient problems: Not Applicable

  MAUDE report 8447862 ↗
• 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 8124184 ↗
• MalfunctionJul 11, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS. / / INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (4) 217863136 MODIFIED HUDSON ADAPTER, LOT NUMBERS TBPKE, H0609, AND TBLTW. THE REMAINING REPORTED 217863136 MODIFIED HUDSON ADAPTER WERE NOT RECEIVED FOR EXAMINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7676919 ↗
• MalfunctionJul 11, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS. INVESTIGATION METHOD: THE COMPLAINT SAMPLE CONSISTED OF (4) 217863136 MODIFIED HUDSON ADAPTER, LOT NUMBERS TBPKE, H0609, AND TBLTW. THE REMAINING REPORTED 217863136 MODIFIED HUDSON ADAPTER WERE NOT RECEIVED FOR EXAMINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7676898 ↗
• MalfunctionMay 14, 2018Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REAMERS HAVE STRIPPED FROM USE . NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510145 ↗
• MalfunctionMar 21, 2018Naturally Worn; Naturally Worn

  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 7356859 ↗
• MalfunctionMar 15, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS NEED A REPAIR. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341052 ↗
• 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 6746580 ↗