INHANCE 6205-10-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 10603295539421), received between Oct 21, 2021 and Jun 1, 2026 — classified as 191 malfunctions.

The most frequently reported specific device problem is “Break” (118 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THREADS ARE STRIPPED ON INSERTER. REAMER SHAFT WILL NOT HOLD REAMER. CUT GUIDE PRODUCES METAL SHAVING WHEN PLACING PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350709 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY THE DRIVER PLASTIC BROKE AT THE TIP. THE BASEPLATE INSERTER AND THE GLENOSPHERE INSERTER DID NOT THREAD TOGETHER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218820 ↗
• MalfunctionMay 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THREADS HAD STRIPPED ON THE INSERTER. THE REAMER REMAINED ON THE REAMER SHAFT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209383 ↗
• MalfunctionMay 13, 2026Break; Device Damaged Prior to Receipt by User; No Apparent Adverse Event

  IT WAS REPORTED THE DRIVER SHAFT WAS NOTED TO HAVE METAL FILINGS WITHIN IT WHEN IT WAS USED FOR THE FIRST TIME DURING A HOSPITAL DEMONSTRATION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163426 ↗
• MalfunctionApr 14, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH OF THE INHANCE (OLDER MODEL) DRIVERS WILL NOT CONSISTENTLY STAY ATTACHED TO THE DRILL HANDPIECE. THEY BOTH NEED TO BE REPLACED WITH THE NEWER UPDATED VERSION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870515 ↗
• MalfunctionApr 14, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH OF THE INHANCE (OLDER MODEL) DRIVERS WILL NOT CONSISTENTLY STAY ATTACHED TO THE DRILL HANDPIECE. THEY BOTH NEED TO BE REPLACED WITH THE NEWER UPDATED VERSION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870513 ↗
• MalfunctionApr 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER SHAFT WAS NOT HOLDING ON TO THE REAMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845023 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT ON UPON OFFICE IN HOUSE INSPECTION, IT WAS FOUND THAT THE INSTRUMENT WAS BROKEN. NO PREVIOUS CASES WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811593 ↗
• MalfunctionApr 6, 2026Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY, THE REAMER WAS LOOSE ON THE ADAPTERS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790590 ↗
• MalfunctionApr 6, 2026Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY THE REAMER WAS LOOSE ON THE ADAPTERS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790583 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT REAMER HANDLE AND SMALL SCREWDRIVER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775773 ↗
• MalfunctionMar 24, 2026Break; Crack

  IT WAS REPORTED THAT THE PLASTIC PORTION AT THE END OF THE SMALL GLENOID REAMER CRACKED ON TWO SIDES AND PIECES FELL OFF WHEN THE TECHNICIAN INSERTED THE REAMER TIP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673819 ↗
• MalfunctionMar 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVER NOT HOLDING REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577762 ↗
• MalfunctionMar 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVER NOT HOLDING REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577758 ↗
• MalfunctionMar 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVER NOT HOLDING REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577757 ↗
• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS DID NOT SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378131 ↗
• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS DID NOT SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378117 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  DURING AN RSA USING INHANCE, DRIVER SHAFT WAS NOT RETAINING REAMER HEADS. ADDITIONALLY, THE GLENOSPHERE INSERTED TIP WOULD NOT THREAD ON TO THE T HANDLE. DEVICE WAS CHECKED AND ITS DAMAGED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272143 ↗
• MalfunctionJan 29, 2026Material Integrity Problem

  IT WAS REPORTED THAT THREADS WERE DAMAGED AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209521 ↗
• MalfunctionJan 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TOTAL SHOULDER REPLACEMENT SURGERY, THE REAMER HANDLE DID NOT HOLD THE REAMERS TIGHT, REAMERS WERE SLIPPING INSIDE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133724 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ENHANCE DRIVERS SHOWING PLASTIC WEAR AROUND REAMER ATTACHMENT AND DISENGAGING EASILY WHEN REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077933 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INHANCE DRIVERS SHOWING PLASTIC WEAR AROUND REAMER ATTACHMENT AND DISENGAGING EASILY WHEN REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077930 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ENHANCE DRIVERS SHOWING PLASTIC WEAR AROUND REAMER ATTACHMENT AND DISENGAGING EASILY WHEN REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077929 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INHANCE DRIVERS SHOWING PLASTIC WEAR AROUND REAMER ATTACHMENT AND DISENGAGING EASILY WHEN REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077928 ↗
• MalfunctionJan 7, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A PROCEDURE THE GLENOID REAMER HANDLE LOST PIECES OF METAL DUE TO RUBBING AGAINST RETRACTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991739 ↗