S-ROM 2576-04-016Recalls & reported problems
Depuy (Ireland) · S-ROM TRIANGLE MILLER CUTTER, GOLD SIZE 16 · 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 10603295145462), received between Jun 29, 2018 and Apr 28, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Material Twisted/Bent1
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.
MalfunctionApr 28, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SROM MILLER FRAME NO LONGER ALLOWS FOR SMOOTH REAMING OF THE CALCAR. UNABLE TO TELL IF IT¿S ONLY THE FRAME OR THE DRILLS. BOTH APPEAR TO HAVE SIGNIFICANT WEAR. NO INSTRUMENTS BROKE INTO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11740075 ↗MalfunctionJun 29, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT ANGLED REAMER (2 SIZES) AND ANGLE MILLER NOT WORKING PROPERLY. REAMER CATCHING UP ON ANGLE MILLER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7651064 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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