ATTUNE 2545-01-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295423591), received between Oct 16, 2023 and Aug 27, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Peeled/Delaminated

  Macro 9/10 tray that was sent for replacement of the other one that had broken plastic, also had broken plastic liner. Product was not put into circulation.No Patient contact.Found prior to circulation and sterilization. Broken Plastic in Cut block size 10 base of tray. Was there any reported patient or user harm? No.Was there a significant delay? No.Additional Information:Broken Plastic in Cut block size 10 section base of the tray. It has a cracked section that is missing plastic when it arrived from Set creations as a replacement product.Product was not put into circulation, and was immediately put aside for return. No Patient contact. Found prior to circulation and sterilization. Reporter stated that they were not aware of any plastic pieces leaving the case or being found in the case when it arrived at the hospital from set creation. The case was not accepted by the hospital.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475535 ↗
• MalfunctionJul 27, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045508 ↗
• MalfunctionMar 10, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICES ARE DELAMINATING ON THE INNER DIVIDERS AND PAINT PEELING ON OUTSIDE OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562748 ↗
• MalfunctionDec 17, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TRAYS EXHIBITED PEELING PAINT AND DELAMINATION ON THE INSIDE. NO PATIENT INVOLVEMENT OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830519 ↗
• MalfunctionOct 24, 2025Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  DURING INITIAL TRAY ASSESSMENT AND INSPECTION PRIOR TO MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT SEVERAL INSTRUMENT TRAYS WITHIN THE ATTUNE KNEE SYSTEM FAMILY OF INSTRUMENT TRAYS CONTAINED GREY COLOURED INNER TRAY LINERS WHICH CONTAIN ENOUGH SPACE ON EACH END BETWEEN THE MAIN OUTER SHELL AND THE GREY INNER TRAY LINER FOR DEBRIS OR MATERIAL TO GET DOWN IN BETWEEN, WITH THE POTENTIAL FOR SAID DEBRIS OR MATERIAL TO REMAIN DOWN IN BETWEEN THE GREY INNER LINER AND THE OUTER TRAY SHELL AND NOT BE ABLE TO BE WASHED AND PROPERLY CLEANED. ALTHOUGH IT WAS SUBSEQUENTLY DETERMINED THAT THE GREY INNER LINER OF THESE COMPLAINED TRAYS CAN IN FACT BE REMOVED, THUS FACILITATING PROPER CLEANING, THE REMOVAL OF THE INNER GREY LINER IS ONLY POSSIBLE WITH THE USE OF AN EXTERNAL TOOL. UPON INSPECTION, BENEATH THE GREY TRAY LINERS ONCE REMOVED, AN ARTICLE (A BIOLOGICAL INDICATOR FROM ANOTHER FACILITY), WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384033 ↗
• MalfunctionMar 27, 2024Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material

  ADDITIONAL INFORMATION N RECEIVED: A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. GOUGE IN BLOCK. D. EVENT DESCRIPTION STATES THAT "CUT BLOCK UNABLE TO USE DUE TO SURFACE DAMAGE." PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED. WAS IT BROKE, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? DEEP LACERATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985640 ↗
• MalfunctionOct 18, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PAINT/MARKING COMING OFF BRAND NEW INSTRUMENT PANS, DURING WASHING AND DRYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956771 ↗
• MalfunctionOct 16, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PAINT/MARKING WAS COMING OFF THE BRAND NEW INSTRUMENT PANS, DURING WASHING AND DRYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944857 ↗