NA 2178-63-173Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295096306), received between Jul 27, 2017 and Mar 22, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (10 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 27 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 16590883 ↗
• 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 12829235 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER STICKS TO THE T-HANDLE AND IS DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211176 ↗
• MalfunctionMay 14, 2021Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825373 ↗
• 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 11090051 ↗
• 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 11046288 ↗
• 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 11027902 ↗
• MalfunctionDec 19, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  THE SURGEON EXPERIENCED PROBLEMS WITH THE MODIFIED HUDSON ADAPTERS (217863136) SPINNING ON THE END OF SEVERAL REAMERS,SPECIFICALLY DUE TO WEAR.

  Patient problems: Not Applicable

  MAUDE report 9496273 ↗
• 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 9241159 ↗
• 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 9241158 ↗
• 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 9240747 ↗
• 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 9240742 ↗
• 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 9238542 ↗
• 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 9129130 ↗
• 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 (B)(4) OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075782 ↗
• 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 8339154 ↗
• 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 8339142 ↗
• 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 8124070 ↗
• MalfunctionSep 24, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED AND WON'T LOCK INTO HUDSON ADAPTOR. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903017 ↗
• 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 7673037 ↗
• MalfunctionJul 5, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT REAMER WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663902 ↗
• 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 7356961 ↗
• 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 7295746 ↗
• 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 7224892 ↗
• 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) (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 INVESTIGA-TION'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 7033856 ↗