ATTUNE 2545-00-026Recalls & reported problems
Depuy (Ireland) · ATTUNE NOTCH GUIDE SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295130437), received between Mar 9, 2020 and Aug 14, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Break” (9 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.
Reports received per month
Most reported problems
Device problems
- Break9
- Naturally Worn6
- Scratched Material5
- Illegible Information4
- Corroded1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient3
- Insufficient Information2
Recent adverse event reports
The 21 most recent of 21 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 22805966 ↗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 22805833 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE SCRATCHED AND DAMAGED. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531806 ↗MalfunctionJul 17, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE SCRATCHED AND DAMAGED. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531796 ↗MalfunctionJan 24, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE NOTCH GUIDE IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570032 ↗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 18463811 ↗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 18463773 ↗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 17632703 ↗MalfunctionApr 10, 2023Break; Crack; Break; Crack
A SMALL PORTION OF THE ATTUNE SIZE 6 NOTCH CUTTING GUIDE WAS FOUND TO HAVE A CRACK AND HAS SINCE BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16709285 ↗MalfunctionMar 15, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16547649 ↗MalfunctionJan 10, 2023Break; Break
IT WAS REPORTED THAT THE NOTCH BLOCK BROKE ON THE ANTERIOR PART INTO TWO PIECES. NOTHING WAS LEFT IN PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135035 ↗MalfunctionOct 19, 2022Break; Break
IT WAS REPORTED THAT THE SIZE 6 NOTCH GUIDE IS CHIPPED AND NEEDS REPLACED. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15631188 ↗MalfunctionSep 16, 2022Break; Break
IT WAS REPORTED AS A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD OVER COURSE OF THE WEEK. INSTRUMENTS ARE ALL FROM CONSIGNMENT SETS. THE LIST CONTAINS MATERIAL ITEM NUMBERS BUT NO DESCRIPTION AS TO HOW THEY BROKE OR THE EXTENT OF THEIR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15438460 ↗MalfunctionAug 5, 2022Corroded; Corroded
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS IS DAMAGED AFTER CLEANING. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173697 ↗MalfunctionMay 16, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE PAINTED NUMBERS ON ATTUNE INSTRUMENTS SHEDDING WHITE PAINT FROM NUMBERED CUTTING BLOCK DURING PREPARATION IN STERILIZING DEPARTMENT FOR USE. CONCERNS THE DEBRIS COULD END UP IN A PATIENT'S WOUND AS A FOREIGN BODY. ATTUNE PS NOTCH CUTTING GUIDES. PRODUCT NO AND LOT NUMBERS UNIDENTIFIED ON PRODUCT SEARCH. EVERY EFFORT MADE TO LOCATE PRODUCT ON THE SEARCH FUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14414253 ↗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 12933605 ↗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 11826141 ↗MalfunctionDec 21, 2020Break; Break
SOME PIECES AND DEVICES FROM ATTUNE INSTRUMENTS HAVE COLOR SIZES RECORDED. FROM ONE OF THE PIECES, SIZE 6 WAS RELEASED. THERE IS A DANGER OF THIS "FILM" WITH THE NUMBER BEING IN THE PATIENT´S JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11049984 ↗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 9964472 ↗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 9964463 ↗MalfunctionMar 9, 2020Break; Break
SIZE 6 ATTUNE NOTCH BLOCK'S RL PHLANGE WAS BROKEN WHEN WE OPENED STERILE TRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9807769 ↗
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 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-158Depuy (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 13, 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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