INHANCE 6205-60-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295539506), received between Jul 10, 2024 and Nov 14, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT A TOOTH FROM A LARGE GLENOID BOW-TIE REAMER BROKE OFF WHILE PREPARING THE GLENOID BASEPLATE. ALL PIECES WERE RETRIEVED, SURGICAL TIME WAS NOT PROLONGED, AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556575 ↗
• InjuryOct 28, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT HAD HARD BONE AND WAS DIFFICULT REAMING. GLENOID WAS IMPLANTED. UPON X-RAY THERE WAS FOREIGN OBJECTS SURROUNDING THE GLENOID POST. THEY INSPECTED THE INSTRUMENTS AND NOTICED THAT THE TIPS OF THE CENTER DRILL FROM THE LG DRILL WERE SHEERED OFF. THEY HAVE BROKE DURING THE TEAMING PROCESS. AN ATTEMPT TO REMOVE THE BROKEN TIPS WAS NOT PERFORMED BECAUSE THE FINAL IMPLANT HAD BEEN INSERTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23401585 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT THE REAMER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23156416 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTATION BROKE FROM THE SET. IT WAS NOTICED BEFORE THE CASE. A NEW SET WAS BROUGHT TO NOT DELAY THE CASE. THERE WAS NO DELAY. NO BROKEN PIECES LEFT ON FIELD OR PATIENT. NO SURGEON COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088724 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING TEETH OF THE CENTRAL PART OF THE LARGE BOWTIE REAMER BROKE OFF WHILE REAMING THE GLENOID. ALL PIECES WERE REMOVED. IT DID NOT NEGATIVELY AFFECT THE CASE AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069374 ↗
• MalfunctionMay 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GLENOID REAMER METAL TWISTED. NO HARM WAS DONE TO PATIENT, NO DELAY HAPPENED AS BACKUP TRAYS WERE AVAILABLE; NO BROKEN PIECES WERE LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054815 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE LARGE BOWTIE GLENOID REAMER BROKE WHILE REAMING THE GLENOID. FRAGMENTS WERE GENERATED AND WERE RETRIEVED. THE LARGE BLAZER FUSED ONTO THE CANNULATED HANDLE. THERE WAS NO MISHANDLING OF THE PRODUCT BEFORE OR AFTER ASSEMBLING THE TWO ITEMS. THERE WAS ABOUT A 20 MINUTE TIME DELAY TO TRY TO REMOVE THE BLAZER FROM THE CANNULATED HANDLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158356 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE LARGE BOW TIE REAMER BROKE DURING SURGERY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20565383 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GLENOID REAMER BROKE INTO PIECES. ALL PIECES WHERE REMOVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19972219 ↗
• 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 19716845 ↗
• MalfunctionJul 10, 2024Failure to Cut; Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716841 ↗
• MalfunctionJul 10, 2024Failure to Cut; Failure to Cut

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716840 ↗
• 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 19716012 ↗