S-ROM 53-4314Recalls & reported problems
Depuy (Ireland) · S-ROM SLEEVE INTRODUCER 14mm · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295171911), received between Jul 29, 2019 and Aug 31, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
- No Apparent Adverse Event1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Not Applicable1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026No Apparent Adverse Event
It was reported that the device had an unknown allegation. It did not happened in surgery.During manufacturer's investigation of the returned device it was identified that the SROM SLEEVE INTRODUCER SZ 14 had signs of normal and constant usage in a clinical setting over the years; such as nick marks at the distal section, scuff marks and slight deformation at the proximal section borders.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525482 ↗MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN ATTEMPTING TO FIT SLEEVE INTRODUCING INSTRUMENT TO THE SLEEVE DRIVER HANDLE, THE SURGEON HAD DIFFICULTY FITTING THE SIZE 12, AND RELEASING IT OFF THE DRIVER HANDLE. THE SIZE 14 DID NOT FIT ONTO THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12232323 ↗MalfunctionJul 29, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A THA, WHILE ASSEMBLING THE SROM INSTRUMENTS, THE SIZE 14 SLEEVE INTRODUCER GOT STUCK ON THE HANDLE. IT WAS FORCIBLY REMOVED. THE DOCTOR ENDED UP GOING TO THE NEXT SIZE SO THE ITEM WASN¿T USED OR NEEDED. SURGICAL DELAY 5 MINUTES.
Patient problems: Not Applicable
MAUDE report 8836038 ↗
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