ATTUNE 2545-11-182Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM FIXED BEARING CENTER TIBIAL DRILL NON-CEMENTED · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295499220), received between May 22, 2023 and Sep 22, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation3
- Break1
- Device-Device Incompatibility1
- Difficult to Advance1
- Illegible Information1
- Mechanical Jam1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Deformation; Unintended Movement
It was reported that during a Total Knee Arthroplasty (TKA) the conical drill had a defect on the top connection portion that locks into the hudson adaptor and it wobbled very badly. After the reporter looked at it the reporter noticed it bent and grabbed another tray to complete the prep portion for the tibia on this surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849734 ↗MalfunctionAug 26, 2026Material Deformation; Illegible Information
It was reported that Center FB drill was found to be bent and would fit thru the bushing. They just opened a new tray. There was no delays. No patient was harmed drill was being returned and no pieces came off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50451153 ↗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 25278520 ↗MalfunctionAug 22, 2025Break; Break
IT WAS REPORTED THAT METAL BURRS ON ATTUNE CEMENTLESS FB TIB DRILL PREVENTED IT FROM GOING DOWN THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873415 ↗MalfunctionApr 30, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SCREW BACKED OUT ON DRILL AT THE COLLAR. SLEEVE (STOP) WILL NOT SLIDE OVER DRILL.
Patient problems: Insufficient Information
MAUDE report 21935321 ↗MalfunctionMay 22, 2023Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT THE SURGEON INSERTED REAMER INTO BUSHING TO REAM THE TIBIA. SURGEON BEGAN TO REAM AND THE CENTER DRILL GOT STUCK AND GRABBED INSIDE THE BUSHING. SURGEON BELIEVES THE CENTER DRILL IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16974663 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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