ATTUNE 2545-00-030Recalls & reported problems
Depuy (Ireland) · ATTUNE NOTCH GUIDE SIZE 10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295130475), received between Aug 10, 2021 and Jun 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn2
- Break1
- Illegible Information1
- Material Discolored1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Break; Material Discolored; Illegible Information; Break; Material Discolored; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT BROKE. ILLEGIBLE ETCHING DUE TO DISCOLORATION.
Patient problems: Insufficient Information
MAUDE report 19624427 ↗MalfunctionApr 8, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. GOUGE IN BLOCK. D. EVENT DESCRIPTION STATES THAT "CUT BLOCK UNABLE TO USE DUE TO SURFACE DAMAGE." PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED. WAS IT BROKE, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? DEEP LACERATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19057945 ↗MalfunctionAug 10, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE MARKINGS ON THE ATTUNE INSTRUMENTS WERE FOUND DAMAGED DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12301949 ↗MalfunctionAug 10, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE MARKINGS ON THE ATTUNE INSTRUMENTS WERE FOUND DAMAGED DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12301830 ↗
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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