INHANCE 7505-10-103Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM STAR DRIVER 20 · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295552611), received between Dec 12, 2024 and Sep 29, 2026 — classified as 8 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.
Reports received per month
Most reported problems
Device problems
- Break8
- Entrapment of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933102 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933096 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298271 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, A DRIVER TIP BROKE OFF WHEN IMPLANTING THE LOCKING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067253 ↗MalfunctionOct 16, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TIP OF THE T20 DISPOSABLE SCREW DRIVER BROKE OFF INSIDE A LOCKING SCREW. SURGEON COULD NOT GET IT OUT SO HE JUST LEFT IT IN THERE.
Patient problems: Foreign Body In Patient
MAUDE report 23313112 ↗MalfunctionJun 17, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER BLADE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22229826 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21856467 ↗MalfunctionDec 12, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE TINE OF THE T20 SCREWDRIVER BROKE OFF WHILE TIGHTENING PERIPHERAL SCREW. THE PIECE WAS MORSE TAPERED INTO SCREW, WAS NOT REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 20911869 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- 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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