S-ROM 2576-02-027Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM TRIPLE BAND CONE REAMER SIZE 27 · Class 1
All models of S-ROM (92)
Data updated Oct 18, 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 10603295145387), received between Apr 27, 2020 and Nov 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (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
- Illegible Information2
- Naturally Worn2
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2023Material Discolored; Naturally Worn; Illegible Information; Material Discolored; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS SIZING AND COLOR MARKINGS ARE FADED, WORN AND DIFFICULT TO SEE. DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18101349 ↗MalfunctionApr 27, 2020Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT WEAR AND TEAR, UNABLE TO READ IN SURGERY. SALES REPRESENTATIVE INDICATED NEED FOR REPLACEMENT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10000539 ↗
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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