NA 2178-63-175Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295096320), received between Jul 27, 2017 and Mar 22, 2023 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 25 most recent of 25 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 16590860 ↗
• MalfunctionMar 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT MBT REAMER KEEPS GETTING STUCK ON THE MODIFIED HUDSON ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566830 ↗
• MalfunctionFeb 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  REAMER IS DAMAGED AND WILL NO LONGER ATTACH TO ADAPTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501651 ↗
• 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 12829234 ↗
• 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 11027929 ↗
• MalfunctionMay 21, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER END STRIPPED AS SURGEON WAS DOING THE CASE. THE STEM TRIAL ATTACHMENT NUBS BROKE OFF AS SURGEON WAS PREPPING THE TIBIAL SLEEVE. SURGICAL DELAY 10 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10080430 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT UPON CHECKING QUICK CONNECT ENDS ON REAMERS AND ADAPTERS, THEY WERE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241188 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; 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 9240846 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240677 ↗
• 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 9240609 ↗
• MalfunctionSep 17, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMERS, T-HANDLE, AND ADAPTORS CONNECTIONS ARE WORN. THE WRENCH WAS BENT. THE VIEW PLATE WAS CRACKED INTO TWO PIECES AND ALL INSTRUMENTS NEEDS REPLACEMENT. THESE ARE ALL OUT OF OFFICE SETS REPLACED TO CHARLOTTE OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075879 ↗
• MalfunctionJul 17, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT HUDSON/REAMERS WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799827 ↗
• MalfunctionFeb 15, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  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 8345056 ↗
• MalfunctionFeb 15, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  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 8345054 ↗
• 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 8330808 ↗
• 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 8124129 ↗
• 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 7673057 ↗
• 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 7510111 ↗
• MalfunctionMay 2, 2018Loose or Intermittent Connection; Device-Device Incompatibility; Naturally Worn; Loose or Intermittent Connection; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE STEM TIGHTENING DEVICE IS STUCK AND WILL NOT TURN. REAMER ADAPTER WILL NOT HOLD THE REAMERS. REAMER ADAPTER T HANDLE WILL NOT HOLD THE REAMERS. ALL OF THE REAMERS WRITTEN UP WILL NOT STAY CONNECTED IN THE ADAPTER; THEY SLIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479252 ↗
• 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 7357008 ↗
• MalfunctionFeb 23, 2018Dull, Blunt; Dull, Blunt

  THE REAMERS ARE STRIPPED AND BEING RETURNED AS WELL. THE SURGEON NOTICED THAT WITH EACH REAMER IT WOULD NOT GRASP WHILE REAMING THE BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291785 ↗
• 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 7225116 ↗
• 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 7033983 ↗
• MalfunctionNov 15, 2017Dull, Blunt; Naturally Worn; Dull, Blunt; 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. 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(B)(4). / / 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 7033965 ↗
• 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 6746597 ↗