S-ROM 2576-02-015Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM TRIPLE BAND CONE REAMER SIZE 15 · Class 1
All models of S-ROM (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295145325), received between Sep 19, 2019 and Sep 19, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (1 report).
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.
Most reported problems
Device problems
- Dull, Blunt1
- Material Deformation1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2019Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation
IT WAS REPORTED THAT THE SURGEON COMPLAINED ABOUT THE SROM AUXILLIARY TRAY INSTRUMENTS. THERE ARE THREE CONICAL REAMERS IN THAT TRAY. UNFORTUNATELY I DO NOT KNOW THE PART NUMBERS. TWO COMPLAINTS. THE MARKINGS ARE TERRIBLY WORN AND EXTREMELY DIFFICULT TO READ WHICH MADE THE CASE CHALLENGING. THE REAMERS HAD A VERY DIFFICULT TIME CUTTING INTO THE BONE AND PROBABLY NEED TO BE SHARPENED. SURGICAL DELAY OF 10 MINUTES.
Patient problems: Not Applicable
MAUDE report 9086728 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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