S-ROM 2576-08-020Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM MI TRIANGLE MILLER CUTTER SIZE 20 · Class 1
All models of S-ROM (92)
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 10603295145752), received between Feb 9, 2021 and Feb 18, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REAM WITH THE ANGLED REAMER THE REAMER GOT STUCK IN THE TRIANGLE MILLER, SO THE SALES REP OPENED ANOTHER SET BECAUSE HE WANTED TO BURRY THE ANGLED REAMER DOWN MORE AND THE SAME THING HAPPENED WITH THE 2ND SET HE OPENED. THE REAMERS NOW WON¿T MOVE FREELY WITHIN THE ANGLED MILLER, SO BOTH THE REAMER AND THE ANGLED MILLERS NEEDS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728575 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THE BAR IS MISSING AND DEVICE IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596910 ↗MalfunctionFeb 9, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE CUTTER GOUGED, DAMAGED. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11301443 ↗
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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