INHANCE 6205-60-060Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE X-Large · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295539513), received between Jul 10, 2024 and Jun 8, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (5 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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut5
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Break; Failure to Cut
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT. THE REAMER WAS DAMAGED ON THE METAL ANCHOR. THE TEETH WERE CHIPPED AND NOT CUTTING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436666 ↗MalfunctionJan 30, 2025Break; Break
IT WAS REPORTED THAT THE GLENOID REAMER BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21275600 ↗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 19716843 ↗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 19716842 ↗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 19716839 ↗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 19716838 ↗
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- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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