ATTUNE 2545-00-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295130413), received between Mar 21, 2019 and Aug 14, 2025 — classified as 16 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 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 22806655 ↗
• 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 22806529 ↗
• 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 22533383 ↗
• 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 22533075 ↗
• MalfunctionOct 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED ON JULY 22, 2024 THAT THERE WERE DEVICES WITH AN UNKNOWN ISSUE. THE EVENT DID NOT HAPPEN IN SURGERY. DURING VISUAL EXAMINATION OF THE RECEIVED DEVICE IT WAS DETERMINED THE DEVICE WAS WORN AND THE GRAPHICS WERE PEELING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401976 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT ON THE NOTCH GUIDE INSTRUMENTS FOR THE ATTUNE THAT THE PRINTED NUMBERS FELL OFF IN THE MIDDLE OF SURGERY. THEY'RE NOT FADED THE NUMBER FELL OFF LIKE A STICKER FALLING OUT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19320357 ↗
• 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 18463672 ↗
• 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 18463651 ↗
• 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 18397880 ↗
• 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 17632698 ↗
• 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 16102038 ↗
• 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 12933626 ↗
• MalfunctionMay 26, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR LEFT OA. DURING THE SURGERY, WHEN THE SURGEON PERFORMED AN OSTEOTOMY WITH THE INSTRUMENTS, A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED, AND THE BONE STAINED BLACK. THE SURGEON SUSPECTED THAT THE MATERIAL HAD CHANGED AND COMMENTED THAT THE MATERIAL OF THE INSTRUMENTS HAD BECOME LESS EXPENSIVE. WHEN AN OSTEOTOMY WAS PERFORMED WITH A NOTCH GUIDE, AN OSTEOTOMY WAS PERFORMED WITH A RECIPROCATING SAW, BUT THE METAL PART WAS SEVERELY ABRADED. ALSO, THE PRECISION OF THE SLIT SEEMED TO BE POOR, AND A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED. THE SURGEON USED A 1.19 MM BLADE. THE CLEARANCE WITH THE SLIT WAS LARGE, AND THE SURGEON ALSO OPERATED NOT TO TOUCH THE SLIT. THE SURGEON STATED THAT EVEN A NEW INSTRUMENT DID NOT DO THIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890292 ↗
• 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 9972735 ↗
• 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 9972731 ↗
• MalfunctionMar 21, 2019Material Discolored; Material Twisted/Bent; Naturally Worn; Material Discolored; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE PRODUCTS HAVE LOTS OF WEAR AND CANT READ THE NUMBERS. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439472 ↗