S-ROM 53-4320Recalls & reported problems
Depuy (Ireland) · S-ROM SLEEVE INTRODUCER 20mm · Class 1
All models of S-ROM (185)
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 10603295171942), received between Aug 9, 2018 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
- Migration1
- Unintended Movement1
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.
MalfunctionDec 16, 2019Unintended Movement; Migration; Unintended Movement; Migration
IT WAS REPORTED THAT THE INSTRUMENT THAT HAS 2 POSTS THAT ARE EXTENDED ON THE SIDE WERE NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9474265 ↗MalfunctionAug 9, 2018Connection Problem; Connection Problem
(B)(6) HOSPITAL, (B)(6) 2018. 20MM SLEEVE INTRODUCER BODY NOT CONNECTING PROPERLY TO THE S-ROM SLEEVE INSERTER HANDLE. PROF (B)(6) HAD TO FORCE IT ON USING A MALLET IN ORDER TO USE THE INSTRUMENT. NO DELAY TO PROCEDURE. NO AE TO PATIENT. (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7769477 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page