ATTUNE 2545-00-027Recalls & reported problems
Depuy (Ireland) · ATTUNE NOTCH GUIDE SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295130444), received between Apr 4, 2018 and Aug 14, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (7 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 Worn7
- Break6
- Illegible Information5
- Scratched Material5
- Crack1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient4
- Insufficient Information3
Recent adverse event reports
The 20 most recent of 20 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 22805950 ↗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 22805930 ↗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 22531771 ↗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 22531678 ↗MalfunctionApr 9, 2024Break; Break
IT WAS REPORTED THAT BLACK NOTCH BOX BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19075979 ↗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 18570169 ↗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 18463790 ↗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 18463715 ↗MalfunctionMay 3, 2023Break; Break
IT WAS REPORTED THAT DURING SURGERY A CHIP CAME OFF THE INSIDE OF THE METAL NOTCH GUIDE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16859399 ↗MalfunctionFeb 21, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE PS NOTCH CUTTING GUIDE EMITTING METAL SHAVINGS FROM SAWBLADE CUTS. THERE WAS NO DELAY TO CASE.
Patient problems: Insufficient Information
MAUDE report 16408873 ↗MalfunctionNov 21, 2022Crack; Crack
IT WAS REPORTED THAT THE BLACK BOX WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15833041 ↗MalfunctionJun 14, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THESE 2 INSTRUMENTS WERE MAL ALIGNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14686431 ↗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 14414287 ↗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 12933608 ↗MalfunctionJul 9, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE METAL PART ON THE TOP OF THE BOX CUT HAS WORN DOWN FROM THE SAW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12145491 ↗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 11826136 ↗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 9964467 ↗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 9964465 ↗MalfunctionJan 6, 2020Break; Illegible Information; Break; Illegible Information
ONE OF THE LETTERS ON THE PS NOTCH CUTTING BLOCK CAME OFF WHILE IN THE STERILE PROCESSING DEPARTMENT. THIS DID NOT CAUSE A DELAY IN SURGERY AND ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9553538 ↗MalfunctionApr 4, 2018Naturally Worn; Naturally Worn
WHITE BACK GROUND OF LETTERING HAS COME OFF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7395471 ↗
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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