S-ROM 2576-08-000Recalls & reported problems
Depuy (Ireland) · S-ROM MINIMALLY INVASIVE TRIANGLE MILLER FRAME · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295145707), received between May 30, 2018 and Oct 26, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Twisted/Bent1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT HAS BENT OVER TIME, WITH USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18013281 ↗MalfunctionJun 17, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INSTRUMENTS WERE DAMAGED FROM PREVIOUS SROM CASES. FOUND TO BE DAMAGED AT THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12021079 ↗MalfunctionOct 22, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE REAMER HANDLE WAS BENT AT THE BOTTOM PART, AND IT CANNOT ACCEPT THE REAMER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10717606 ↗MalfunctionMay 20, 2019Break; Break
HANDLE ON MILLER FRAME BROKE OFF DURING REMOVAL. METAL FATIGUE. NO ISSUE TO THE PATIENT. NO DELAY TO THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625694 ↗MalfunctionMay 30, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE MILLING FRAME JAMMED UP AND WOULDN¿T ADVANCE TO REAM FOR SPOUT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7552765 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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