INHANCE 6205-60-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295539483), received between Mar 31, 2023 and Jul 1, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE INSTRUMENT HAD A MANUFACTURING DEFECT. THE CANNULATION WAS TOO SMALL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373204 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVERS ARE STRIPPED, THE INSERTER HANDLE BROKE, AND THE GLENOID REAMER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341086 ↗
• MalfunctionSep 30, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SMALL BOW TIE GLENOID REAMER WON'T STAY ON THE REAMER SHAFT. SURGEON THINKS IT IS WORN AND NEEDS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332821 ↗
• 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 19706005 ↗
• 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 19705930 ↗
• 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 19704891 ↗
• 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 19704289 ↗
• MalfunctionApr 19, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING THE PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON NOTED THAT THE SMALL BOW TIE GLENOID REAMER WAS DULL. THERE WERE NO PIECES BROKEN OFF. THERE WERE NO COMPLICATIONS OR DELAYS TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149663 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19058024 ↗
• MalfunctionMar 18, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT GLENOID REAMER WAS DAMAGED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922358 ↗
• MalfunctionJan 22, 2024Break; Naturally Worn; Break; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO, THIS HAPPENED POST-OP. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552089 ↗
• MalfunctionJan 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE BOWTIE REAMER WAS GETTING DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534772 ↗
• MalfunctionSep 12, 2023Corroded; Failure to Cut; Corroded; Failure to Cut

  IT WAS REPORTED THAT DURING INSPECTING INSTRUMENTS WHILE PUTTING THE TRAYS TOGETHER THEY NOTICED THE BOW TIE REAMER, SIZE SMALL ITEM # 6205-60-030, LOT #10032 WAS BEGINNING TO SHOW SIGNS OF PITTING AROUND THE CUTTING FLUTES. THEY REMOVED IT FROM THE SET AS IT WAS BELIEVED THAT THIS INSTRUMENT IS NO LONGER GOING TO CUT THROUGH BONE AS EASILY. THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729449 ↗
• MalfunctionApr 13, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED, THAT THE REAMER IS BECOMING DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16738268 ↗
• MalfunctionApr 6, 2023Corroded; Corroded

  IT WAS REPORTED THAT AFTER DECONTAMINATION, SPD DIRECTOR THAT THE SMALL BOWTIE GLENOID REAMER WAS SHOWING SIGNS OF PITTING. THIS HAPPENED POST OP. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691048 ↗
• MalfunctionMar 31, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE REAMER IS DULL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658907 ↗