ATTUNE 2545-00-153Recalls & reported problems
Depuy (Ireland) · ATTUNE A-P CHAMFER BLOCK SIZE 3 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295395348), received between Sep 25, 2019 and Jun 27, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation16
- Naturally Worn4
- Corroded3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350041 ↗MalfunctionMay 27, 2025Material Deformation; Material Deformation
METAL ON SIZE 3 CUTTING BLOCK HAS BEEN DAMAGED DUE TO OVERUSE. STERILE PROCESSING DEPARTMENT WILL NOT PROCESS DUE TO DAMAGE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090913 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095795 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095793 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095792 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095791 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095779 ↗MalfunctionNov 13, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE A-P CHAMFER BLOCK SIZE 3 HAS A SHARP EDGE AND NEEDS REPLACING NO EVENT. WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18118592 ↗MalfunctionAug 12, 2022Break; Break
IT WAS REPORTED THAT THE SIZE 3 4-1 CUTTING BLOCK METAL GENERATED FRAGMENTS FROM SAW BLADE DURING PROCESSING THE INSTRUMENT BY SPD. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15216678 ↗MalfunctionSep 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CUTTING BLOCKS HAVE BEEN WORN OVER TIME BY THE SAW BLADE, MAKING THEM DIFFICULT TO USE FOR THE SURGEON IN THE CASE. HE HAS REQUESTED NEW BLOCKS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12549994 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871183 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871182 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871176 ↗MalfunctionOct 25, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionSep 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE 4 IN 1 BLOCKS WERE FRAYED ON EDGES WERE TEARING GLOVES. NEED TO BE DULLED DOWN OR REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119223 ↗MalfunctionSep 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE 4 IN 1 BLOCKS WERE FRAYED ON EDGES WERE TEARING GLOVES. NEED TO BE DULLED DOWN OR REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119220 ↗
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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