INHANCE 6205-60-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295539476), received between Jul 9, 2024 and Jul 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: NO ADVERSE OUTCOMES SURGEONS COULD JUST TELL REAMERS DULL-HAD TO APPLY EXTRA FORCE TO REAMER SHAFT TO SEAT REAMER TO APPROPRIATE LEVEL. WILL CIRCLE BACK AND TRY TO PROVIDE REAMER LOT #S BUT VERY WORN ON REAMERS-HARD TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706021 ↗
• MalfunctionJul 9, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE INHANCE BOW TIE REAMERS WERE DULL. THE CUTTING TEETH WERE NOT SHARP ENOUGH. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704602 ↗
• MalfunctionJul 9, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: NO ADVERSE OUTCOMES SURGEONS COULD JUST TELL REAMERS DULL-HAD TO APPLY EXTRA FORCE TO REAMER SHAFT TO SEAT REAMER TO APPROPRIATE LEVEL. WILL CIRCLE BACK AND TRY TO PROVIDE REAMER LOT #S BUT VERY WORN ON REAMERS-HARD TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704459 ↗
• MalfunctionJul 9, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE INHANCE BOW TIE REAMERS WERE DULL. THE CUTTING TEETH WERE NOT SHARP ENOUGH. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704276 ↗