INHANCE 6205-60-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539490), received between Mar 18, 2024 and Sep 30, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the INHANCE device was dull and missing one of the tips. It was reported that the event did not happen in surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946037 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE REAMER (THE BARREL) BROKE IN TWO PIECES. THEY HAD TO OPEN A NEW SET AND USE C-ARM TO MAKE SURE NOTHING WAS LEFT IN THE JOINT. SURGERY WAS EXTENDED BY TEN TO FIFTEEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115499 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE CENTER POST OF REAMER BROKE OFF IN PATIENT WHILE REAMING. ALL PIECES WERE RETRIEVED. NOTHING WAS OUT OF THE ORDINARY WHILE REAMING, IT JUST BROKE OFF. THERE WAS SLIGHT DELAY WHILE FISHING THE REAMER OUT OF THE PATIENT WITH A NEURO HOOK. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151184 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE CENTER POST OF REAMER BROKE OFF IN PATIENT WHILE REAMING. ALL PIECES WERE RETRIEVED. NOTHING WAS OUT OF THE ORDINARY WHILE REAMING, IT JUST BROKE OFF. THERE WAS SLIGHT DELAY WHILE FISHING THE REAMER OUT OF THE PATIENT WITH A NEURO HOOK. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151167 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER GOT STUCK DUE TO BEING DULL PER THE SURGEON. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008717 ↗
• MalfunctionMar 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON WAS DOING A TSA ON THIS PATIENT AND STATED THE GLENOID REAMER WAS NOT REAMING LIKE IT SHOULD BE AND THE PIN WAS BINDING UP INSIDE THE REAMER, CONSIDERING THE PATIENT HAD RELATIVELY SOFT BONE. A REAMER OUT OF ANOTHER SET WAS USED WITHOUT ISSUE. NO ADVERSE EVENT TO PATIENT TO REPORT, NO BROKEN PIECES, THE SURGICAL DELAY WAS APPROXIMATELY 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542727 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT THE REAMER TIP BROKE OFF. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES TO GET THE TIP OUT OF THE PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143080 ↗
• MalfunctionJul 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INHANCE BOW TIE REAMERS WERE DULL. THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716836 ↗
• MalfunctionJul 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INHANCE BOW TIE REAMERS WERE DULL. THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715830 ↗
• 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 19704304 ↗
• 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 19704228 ↗
• MalfunctionMar 18, 2024Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE MEDIUM GLENOID REAMER WAS VERY DAMAGED, NO PATIENT HARM/ DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920732 ↗