NA 2178-63-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295096047), received between Sep 14, 2017 and Feb 26, 2024 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WOULD NOT SECURELY HOLD WHILE REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777625 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WOULD NOT SECURELY HOLD WHILE REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777610 ↗
• MalfunctionAug 9, 2022Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LCS COMPONENTS ARE NOT ENGAGING PROPERLY. THE END OF BROACH INSERTER IS CRACKED. THE BACK END OF DEPTH GAUGE KEEPS FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191230 ↗
• MalfunctionApr 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT NEITHER MBT CONCICAL REAMER WILL MATE WITH STEM TRIALS. STEM TRIALS WOULD DISENGAGE FROM REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653131 ↗
• MalfunctionDec 22, 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 11057356 ↗
• MalfunctionMar 5, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  THE REAMER HAS A STOPPER THAT SLIDES OVER IT. THE STOPPER IS NOT SLIDING WELL BECAUSE EXCESSIVE WEAR ON THE REAMER. NO PICTURE WAS TAKEN AS THERE IS NOTHING TO SEE BUT IT NEEDS TO BE REPLACED AS IT IS NOT WORKING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794170 ↗
• 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 9496221 ↗
• MalfunctionOct 24, 2019Dull, Blunt; Dull, Blunt

  REPLACE RING SHARPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233793 ↗
• MalfunctionOct 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REAMER AND ADAPTER WERE BOTH STRIPPED OUT DURING SURGERY NEITHER WORK ANYMORE. NO BROKEN PIECES JUST STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225934 ↗
• MalfunctionJul 25, 2019Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE STEM WOULD NOT SEAT IN EITHER REAMER. STEM ALSO BECAME STUCK IN REAMER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826308 ↗
• MalfunctionJul 16, 2019Dull, Blunt; Material Deformation; Naturally Worn; Dull, Blunt; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE T HANDLE AND HUDSON ADAPTER HAVE STRIPPED AT THE ENDS. CONICAL REAMERS ARE DULL AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795391 ↗
• InjuryDec 21, 2018Naturally Worn; Naturally Worn

  THE INSTRUMENTS WERE WORN.

  Patient problems: No Code Available

  MAUDE report 8190845 ↗
• MalfunctionDec 20, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TOP OF THE REAMERS WERE WORN AND WOULD NOT LOCK INTO HUDSON ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185557 ↗
• MalfunctionDec 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CONNECTION PIECE FROM THE COMICAL REAMERS TO THE T-HANDLE AND HUDSON ADAPTER HAVE STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8128797 ↗
• MalfunctionOct 9, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS WON¿T ACCEPT TRIAL STEMS - BECOME JAMMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948342 ↗
• 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 7479384 ↗
• 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 7357284 ↗
• MalfunctionJan 12, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE REAMERS HAVE STRIPPED OUT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185686 ↗
• MalfunctionJan 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CONNECTION FOR FLARED REAMER NO LONGER WORKS. WILL NOT CONNECT TO ADAPTER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171234 ↗
• MalfunctionSep 14, 2017Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT THE REAMERS DO NOT WORK WELL; THE COUPLING SYSTEM TO THE DRILL DOES NOT WORK. REVISION B REAMERS (PRODUCTS D 217863106 AND D 217863104) MUST BE REPLACED.

  Patient problems: No Information

  MAUDE report 6864321 ↗