INHANCE 7000-35-230Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOID PIN Ø3.5mm x 230mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295550402), received between Oct 21, 2024 and Oct 15, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT GLENOID PIN IS TOO LARGE FOR THE GLENOID REAMER. IT WOULD NOT SLIDE DOWN THE SHAFT OF THE PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291289 ↗MalfunctionJun 2, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIECES GOT STUCK TOGETHER. THE PIN WOULD NOT PULL OUT OF SIZER HANDLE AFTER ATTEMPTING TO PUT IT INTO GLENOID THROUGH GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124172 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023
Patient problems: Unspecified Infection
MAUDE report 20497215 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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