ATTUNE 2545-11-455Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295499350), received between Oct 10, 2023 and May 26, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT NON-CEM FB TIBIAL DRILL AND DRILL BUSHING WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278427 ↗
• MalfunctionApr 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE DEVICE WAS CONSIDERED UN-USABLE BECAUSE THE REAMER COULD NOT PASS THROUGH IT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004387 ↗
• MalfunctionApr 17, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT WHILE DRILLING THROUGH THE TIBIAL PREP TOWER FOR THE CENTRAL KEEL WITH AN ATTUNE CEMENTLESS KEEL DRILL BIT, THE BIT BECAME BOUND INSIDE THE TOWER AND REQUIRED MALLET BLOWS TO SEPARATE THE TWO PIECES. UPON INSPECTION, EACH PIECE WAS HEAVILY SCORED AND NECESSITATED REPLACEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911758 ↗
• MalfunctionMar 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NON-FEM FB DRILL BUSHING WAS NOT WORKING CORRECTLY. TIBIA DRILL WAS GETTING STUCK IN IT. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632897 ↗
• MalfunctionMar 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE NON-FEM FB DRILL BUSHING WAS NOT WORKING CORRECTLY. TIBIA DRILL WAS GETTING STUCK IN IT. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629741 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE SURGEON WAS IMPACTING THE FEMORAL INTRODUCER AND THE RED DIAL ON THE SIDE BROKE OFF. ALSO, WHILE USING THE NON-CEMENTED TIBIAL DRILL, THE DRILL BECAME BOUND UP IN THE BUSHING. THE SURGERY WAS PROCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400545 ↗
• MalfunctionFeb 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BUSHING AND DRILL HAVE IMPINGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304201 ↗
• MalfunctionSep 16, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIBIAL DRILL DID NOT FIT THROUGH THE BUSHING, IT WAS STUCK AND STRIPPED DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064750 ↗
• MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT REAMER GOT STUCK IN TOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742820 ↗
• MalfunctionSep 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL WAS BUSHING AND THE DRILL WILL NOT ADVANCE. IT WOBBLES A LITTLE. THERE WAS NOTHING LEFT IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20277895 ↗
• MalfunctionJul 24, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CEMENTLESS FB TIBIAL PREP BUSHING IS OUT OF SPECIFICATION AND DRILL WILL NOT FIT THROUGH. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19820378 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19555020 ↗
• MalfunctionMar 29, 2024Device-Device Incompatibility; Material Integrity Problem; Naturally Worn; Device-Device Incompatibility; Material Integrity Problem; Naturally Worn

  IT WAS REPORTED THAT WHEN PREPPING THE TIBIA FOR FB PRESSFIT, THE NON-CEM CENTER FB TIBIAL DRILL WOULDN'T FIT DOWN THE FB TIB DRILL BUSHING. THERE SEEMS TO BE THAT THE DRILL AND DRILL BUSHING HAD BECOME DAMAGED WITH PAST USE. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004718 ↗
• MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CENTER TIBIAL DRILL GOT DAMAGED IN SUCH A WAY THAT IT DOES NOT GO THROUGH THE BUSHING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986578 ↗
• MalfunctionOct 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NON-CEM FB TIB DRILL BUSHING HOLE TO SMALL WON'T ACCEPT THE DRILL. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965174 ↗
• MalfunctionOct 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KEEL DRILL WAS STUCK IN THE BUSHING AFTER BEING USED. APPEARS TO HAVE DAMAGE TO BOTH THE DRILL AND THE BUSHING. HAD TO BE EXTRACTED WITH A MALLET. THE DRILL DID NOT PASS FREELY THROUGH THE BUSHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949505 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS WERE STRIPPED AND WOULD NOT FEED THROUGH TOWER DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908554 ↗