NA 2178-63-172Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295096290), received between Jul 27, 2017 and Mar 22, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS NO LONGER ATTACH TO ADAPTOR AND T HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590874 ↗
• 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 12829205 ↗
• MalfunctionApr 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 10 AND 12 REVISION REAMER WOULD STICK WHILE ATTACHED IN T-HANDLE AND WAS DIFFICULT REMOVE. ALL OTHER SIZES USED WOULD NOT STICK. THERE WAS A 30 SECOND DELAY IN THE CASE. LOT NUMBERS ON BOTH REAMERS UNAVAILABLE NOT ABLE TO READ.

  Patient problems: Insufficient Information

  MAUDE report 11693998 ↗
• MalfunctionDec 29, 2020Failure 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 11090057 ↗
• MalfunctionDec 17, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT 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 BROKE 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 11027812 ↗
• MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, HAD COMPLAINTS THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241147 ↗
• MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, HAD COMPLAINTS THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241143 ↗
• MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS. HAD COMPLAINTS THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240724 ↗
• MalfunctionOct 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  CHECK QUICK CONNECT ENDS ON REAMERS AND ADAPTERS. HAD COMPLAINTS  THEY ARE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240723 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT CHECK TOLERANCE ON HUB END COMPLAINTS NOT FITTING PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238389 ↗
• MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9152465 ↗
• MalfunctionOct 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE HUDSON ADAPTOR AND REAMERS THE HUDSON ATTACHMENT AND THE REAMERS STRIPPED AND HAD DIFFICULTY REAMING THE FEMUR AND THE TIBIA. THEY TRIED THIS WITH BOTH SETS OF OUR HUDSON¿S AND T-HANDLES AND REAMERS. ALSO THE SIZE 4 TC3 BOX TRIAL WOULD NOT STAY ON THE FEMUR TRIAL SO THINK THE TORQUE SCREW MUST BE STRIPPED. A SURGICAL DELAY OF 15-20 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 9152461 ↗
• MalfunctionSep 27, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ALL REAMERS ARE STRIPPED AND DO NOT STAY ATTACHED TO THE HUDSON. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129145 ↗
• MalfunctionFeb 14, 2019Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 10-18 MBT REVISION REAMERS ARE DULL AND SKIPPING ON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339163 ↗
• MalfunctionFeb 14, 2019Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

  IT WAS REPORTED THAT THE SIZE 10-18 MBT REVISION REAMERS ARE DULL AND SKIPPING ON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339162 ↗
• 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 8124042 ↗
• MalfunctionJul 10, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENTS NEED A REPAIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673021 ↗
• 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 7510109 ↗
• MalfunctionMar 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356916 ↗
• MalfunctionJan 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE MBT REAMERS SLIPPING IN THE MODIFIED HUDSON ADAPTER WHILE REAMING BONE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7224619 ↗
• MalfunctionNov 15, 2017Dull, Blunt; Dull, Blunt

  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. EXAMINATION OF THE FOUR SUBMITTED ADAPTERS CONFIRMED THE CONNECTION FEATURES THAT ATTACH TO THE REAMER ARE WORN/DAMAGED. THE DAMAGE IS CONSISTENT WITH THE REAMERS MATING FEATURE STRIPPING AFTER BEING SUBJECTED TO HARD CORTICAL BONE AND HEAVY USAGE CAUSING DAMAGE/WEAR TO THE ADAPTER. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE INVESTIGATION'S DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, NO CORRECTIVE ACTION IS BEING PURSUED. CONTINUE TO MONITOR VIA SEP-419. / / INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7033783 ↗
• MalfunctionNov 15, 2017Dull, Blunt; Dull, Blunt

  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 (B)(4) MODIFIED HUDSON ADAPTER, LOT NUMBERS TBPKE, H0609, AND TBLTW. THE REMAINING REPORTED (B)(4) MODIFIED HUDSON ADAPTER WERE NOT RECEIVED FOR EXAMINATION. EXAMINATION OF THE FOUR SUBMITTED ADAPTERS CONFIRMED THE CONNECTION FEATURES THAT ATTACH TO THE REAMER ARE WORN/DAMAGED. THE DAMAGE IS CONSISTENT WITH THE REAMERS MATING FEATURE STRIPPING AFTER BEING SUBJECTED TO HARD CORTICAL BONE AND HEAVY USAGE CAUSING DAMAGE/WEAR TO THE ADAPTER. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT. BASED ON THE INVESTIGATION'S DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, NO CORRECTIVE ACTION IS BEING PURSUED. CONTINUE TO MONITOR VIA SEP-419. / / INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE REAMERS ARE SCARRED AT THE UNION FROM USAGE OVER THE YEARS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7033773 ↗
• 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 6746815 ↗