S-ROM 54-0004Recalls & reported problems
Depuy (Ireland) · S-ROM TRIANGLE MILLER SHELL SIZE 4 · Class 1
All models of S-ROM (185)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295173533), received between Mar 25, 2019 and Sep 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent2
- Device Damaged Prior to Use1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
GUIDES ARE TO WORN AND NOT FUNCTIONAL. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9030792 ↗MalfunctionMar 25, 2019Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent
CENTRAL STERILE NOTICED DAMAGE. IT WAS NOT USED IN THE CASE. CAUSE OF DAMAGE IS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8449282 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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