ATTUNE 2545-00-028Recalls & reported problems
Depuy (Ireland) · ATTUNE NOTCH GUIDE SIZE 8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295130451), received between Jun 22, 2017 and Aug 14, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Naturally Worn4
- Scratched Material4
- Illegible Information2
- Bent1
- Material Erosion1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient3
- Insufficient Information2
- No Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE SCRATCHED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805979 ↗MalfunctionAug 14, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE SCRATCHED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805844 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE ATTUNE NOTCH GUIDE SZ 8 WAS SCRATCHED AND DAMAGED. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531663 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE ATTUNE NOTCH GUIDE SZ 8 WAS SCRATCHED AND DAMAGED. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531649 ↗MalfunctionJan 24, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE NOTCH GUIDES SHOW WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570657 ↗MalfunctionJan 8, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PHYSICIAN STATES NOTCH GUIDES WERE SHOWING WEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 18463872 ↗MalfunctionJan 8, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PHYSICIAN STATES NOTCH GUIDES WERE SHOWING WEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 18463839 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE PART ON NOTCH GUIDE HAS BROKEN OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164074 ↗MalfunctionJan 5, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THE ATTUNE INSTRUMENTS IS DAMAGED AFTER CLEANING. OCCURRED AFTER CLEANING. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102037 ↗MalfunctionApr 15, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964466 ↗MalfunctionApr 15, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964456 ↗MalfunctionMar 28, 2019Break; Break
A LARGE PIECE OF THE NOTCH GUIDE ((B)(4)) HAS BROKEN OFF FROM THE MAIN BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8460874 ↗MalfunctionJun 22, 2017Bent; Material Erosion; Bent; Material Erosion
IT WAS REPORTED THAT UPON CHECKING THE INSTRUMENT PAN POST SURGERY, IT WAS DISCOVERED THAT THE MIDDLE PART OF NOTCH GUIDE WAS BENT AND SCRATCHED/SCORED.
Patient problems: No Information
MAUDE report 6659743 ↗
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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