ATTUNE 2545-00-025Recalls & reported problems
Depuy (Ireland) · ATTUNE NOTCH GUIDE SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune notch guide is a reusable orthopedic cutting instrument. The 24 reports describe wear,
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295130420), received between Apr 17, 2020 and Aug 14, 2025 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (11 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 Worn11
- Scratched Material6
- Break4
- Illegible Information3
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient4
- Insufficient Information2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT ITEMS SCRATCHED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806678 ↗MalfunctionAug 14, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT ITEMS SCRATCHED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806663 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THE INSTRUMENTS ARE SCRATCHED AND DAMAGED. EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534028 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THE INSTRUMENTS ARE SCRATCHED AND DAMAGED. EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22533665 ↗MalfunctionSep 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2024, THE GUIDE WAS FOUND WITH SIGNS OF WEAR AND PEELING GRAPHIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20283368 ↗MalfunctionSep 19, 2024No Apparent Adverse Event; No Apparent Adverse Event
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2024 THAT SHOWS SIGNS OF WORN AND PEELING GRAPHIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255614 ↗MalfunctionJun 5, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE GROOVE FOR BOX CUT IS WORN OUT. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19471946 ↗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 18463757 ↗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 18463739 ↗MalfunctionDec 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE NOTCH CUTTING GUIDE IS WORN, MAKES A LARGER CUT THAN NECESSARY, REPLACEMENT NEEDED. THERE ARE NO BROKEN PIECES OR SURGERY DELAY. INSTRUMENTS WERE NOT LEFT IN PATIENT, GUIDE WAS REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18405670 ↗MalfunctionDec 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE NOTCH GUIDES HAVE WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18397928 ↗MalfunctionAug 28, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT HAS AN UNKNOWN ALLEGATION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17632704 ↗MalfunctionFeb 16, 2023Break; Break
IT WAS REPORTED THE ATTUNE PS NOTCH GUIDE SZ 5 EMITTING METAL DEBRIS FROM SAWBLADE CUTTING THE NOTCH GUIDE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16390227 ↗MalfunctionJan 11, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE METAL BACKSTOP ON THE BOX CUTTING GUIDE IS WEARING FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13226077 ↗MalfunctionJan 11, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE METAL BACKSTOP ON THE BOX CUTTING GUIDE IS WEARING FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13226034 ↗MalfunctionJan 11, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE METAL BACKSTOP ON THE BOX CUTTING GUIDE IS WEARING FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13225982 ↗MalfunctionJan 11, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE METAL BACKSTOP ON THE BOX CUTTING GUIDE IS WEARING FROM USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13225854 ↗MalfunctionDec 6, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE DAMAGED AND NEEDS REPLACING. NO BROKEN PIECES/NO HARM TO PATIENT. INSTRUMENTS ARE WORN AND NEEDS REPLACEMENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12933618 ↗MalfunctionMay 14, 2021Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE NOTCH GUIDES HAVE ALL LOST THE WHITE ON THE NUMBERS AND ALSO HAVE WEAR/GROOVES ON THE METAL SURFACES. THE FEMORAL TRIALS ARE DISCOLORED AND HAVE GOUGES ON THE SURFACE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826159 ↗MalfunctionOct 12, 2020Break; Break
IT WAS REPORTED THAT THE BOX BROKE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10661346 ↗MalfunctionJul 6, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT THE ATTUNE PS FEMORAL TRIAL SZ 6 RT CHIPPED OUT AND THE ATTUNE NOTCH GUIDE SZ 5 HAS GOUGES IN IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10237753 ↗MalfunctionApr 17, 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 9972742 ↗MalfunctionApr 17, 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 9972730 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page