S-ROM 2576-02-019Recalls & reported problems
Depuy (Ireland) · S-ROM TRIPLE BAND CONE REAMER SIZE 19 · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295145349), received between Dec 26, 2018 and Nov 9, 2023 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (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
- Illegible Information8
- Naturally Worn4
- Material Discolored3
- Scratched Material3
- Device-Device Incompatibility2
- Material Twisted/Bent1
- Optical Discoloration1
Patient problems
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 11 most recent of 11 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 18101227 ↗MalfunctionApr 5, 2023Material Discolored; Naturally Worn; Illegible Information; Material Discolored; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE SIZING MARKERS ARE TOO FADED AND WORN. THEY ARE DIFFICULT TO READ. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681683 ↗MalfunctionNov 4, 2021Device-Device Incompatibility; Device-Device Incompatibility
TRIAL SLEEVE WOULD STICK TO TRIAL SLEEVE INSERTER HANDLE AFTER BEING IMPACTED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751129 ↗MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CONE REAMER JAMMED INTO THE CIRCLE SROM OSTEOTOMY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12232150 ↗MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10036511 ↗MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10036504 ↗MalfunctionMay 7, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT INSTRUMENTS CAN¿T BE IDENTIFIED WITH SIZES OR IDENTIFYING MARKERS ANYMORE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10036503 ↗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 10000537 ↗MalfunctionMar 30, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. SURGEON IS CONCERNED THIS IS A PATIENT SAFETY ISSUE AND INSTRUMENTS SHOULD BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9900818 ↗MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732492 ↗MalfunctionDec 26, 2018Material Discolored; Naturally Worn; Optical Discoloration; Material Discolored; Naturally Worn; Optical Discoloration
EXCESSIVE WEAR AND LACK OF SHARPNESS OF SOME S-ROM LOANER SET ESPECIALLY WHEN SOILED WITH BLOOD
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8196845 ↗
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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