NA 2178-63-177Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295096344), received between Jul 27, 2017 and May 12, 2023 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMay 12, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING THE SURGERY THE BIGGER DIAMETER REAMERS DIDN¿T REAM THE CORTICAL BONE WHEN THE SURGEON HAD TO APPLY GREATER FORCE BECAUSE THE REAMER CONTACTED THE CORTICAL BONE. THE T HANDLE MOVED AROUND ON THE REAMER SHAFT, BUT THE REAMER ITSELF STAYED IN THE MEDULLARY CANAL WITHOUT ANY MOVE (WHEN IT SHOULD MOVE WITH THE T HANDLE). IT IS NOT THE FAULT OF THE REAMER OR THE HANDLE, JUST OVERUSED AND WORN. THERE WAS A SURGICAL DELAY OF FOUR MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918677 ↗
• 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 16590875 ↗
• MalfunctionMar 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT BOTH OF THE T-HANDLES LISTED BELOW ARE STRIPPED AND WILL NOT HOLD A REAMER FOR THE DOCTOR TO PERFORM PROPER REAMING. THE SURGEON REQUESTED A NEW ONE TO REPLACE. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED. THE REAMER IS STRIPPED AND WILL NOT HOLD A T-HANDLE FOR PROPER REAMING. SURGEON HAS REQUESTED TO BE REPLACED. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711210 ↗
• 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 12829228 ↗
• MalfunctionFeb 4, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT MBT REVISION REAMERS ARE WORN DOWN AT THEIR ATTACHMENT POINT AND WILL NOT PROPERLY ATTACH TO THE MODIFIED HUDSON ADAPTER AND NEED TO BE REPLACED. PLEASE SEND REPLACEMENTS TO NORTH CAROLINA SPECIALTY HOSPITAL IN DURHAM, NC. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282563 ↗
• MalfunctionJan 5, 2021Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11117508 ↗
• 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 11027924 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241292 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  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 9241252 ↗
• 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 9075880 ↗
• 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 8799860 ↗
• 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 8447864 ↗
• 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 8345082 ↗
• 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 8345080 ↗
• 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 8124151 ↗
• 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 7673086 ↗
• MalfunctionMay 2, 2018Loose or Intermittent Connection; Device-Device Incompatibility; Loose or Intermittent Connection; Device-Device Incompatibility

  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 7479317 ↗
• 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 7357067 ↗
• MalfunctionFeb 26, 2018Naturally Worn; Naturally Worn

  DER STATES THAT ALL PIECES WERE RETRIEVED AND BEING RETURNED. THESE INSTRUMENTS ARE USED AT (B)(6) MEDICAL CENTER BUT OCCASIONALLY USED AT OTHER HOSPITALS. THE RP IMPACTOR BROKE IN HALF WHILE THE SURGEON WAS IMPACTING THE MBT TRAY. THE HUDSON ADAPTOR AND THE REAMERS ARE STRIPPED AND BEING RETURNED AS WELL. THE SURGEON NOTICED THAT WITH EACH REAMER IT WOULD NOT GRASP WHILE REAMING THE BONE. THE REAMERS HAVE BEEN USED FOR 40 PLUS SURGERIES. THE HUDSON ADAPTOR HAS BEEN USED AT LEAST SEVEN TIMES. THE RP TRAY IMPACTOR HAS ALSO BEEN USED ON 40 PLUS SURGERIES. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295829 ↗
• MalfunctionJan 30, 2018Connection Problem; Connection Problem

  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 7227272 ↗
• 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-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 7034303 ↗
• 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 (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 7034277 ↗
• InjuryJul 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 6746572 ↗