S-ROM NOILES 63-3810Recalls & reported problems
Depuy (Ireland) · S-ROM NOILES AUGMENT BLOCK CEMENT CLAMP · Class 1
All models of S-ROM NOILES (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295180722), received between Oct 20, 2017 and Jul 7, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Most reported problems
Device problems
- Break3
- Device-Device Incompatibility1
- Loose or Intermittent Connection1
- Positioning Problem1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2021Break; Break
IT WAS REPORTED THAT THE SROM AUGMENT CLAMP BROKEN. THE CLAMPING PORTION ON THE SCREW MECHANISM IS BROKEN OFF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129402 ↗MalfunctionJul 12, 2019Loose or Intermittent Connection; Device-Device Incompatibility; Positioning Problem; Unintended Movement; Loose or Intermittent Connection; Device-Device Incompatibility; Positioning Problem; Unintended Movement
IT WAS REPORTED THAT THE BOTTOM BLACK RUBBER CLAMP PIECE WAS LOOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8785240 ↗MalfunctionFeb 20, 2019Break; Break
IT WAS REPORTED THAT AS THE SURGEON WAS TIGHTENING THE CLAMP, BOTH BUSHINGS BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8353972 ↗MalfunctionOct 20, 2017Break; Break
IT WAS REPORTED THAT THE STOPPER IS MISSING FROM THE PRODUCT.
Patient problems: No Information
MAUDE report 6965124 ↗
Other CLAMP devices
- ATTUNE 2544-00-001Depuy (Ireland) · CLAMP144 reports
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB461RAesculap AG · CLAMP1 recall0 reports
- ATRAUMATA FB738RAesculap AG · CLAMP1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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