ATTUNE 2545-00-165Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL DRILL CEMENTED LINE TO LINE · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune tibial drill is used to prepare the knee bone for implant surgery during total knee replacement. The 70 reports mostly describe instruments binding, breaking, or wearing out mid-operation, sometimes leaving metal filings or loose fragments in the bone, and in one case a color ring coming loose. There are no deaths and no injuries. No recalls name this device, and the number of reports is steady at 5 in each of the last two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10603295445647), received between Jan 10, 2018 and Sep 29, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (36 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
- Device-Device Incompatibility36
- Break18
- Unintended Movement7
- Naturally Worn5
- Difficult to Advance3
- Material Twisted/Bent3
- Mechanical Jam3
- Scratched Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient15
- Not Applicable5
- Insufficient Information3
- No Code Available2
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device-Device Incompatibility; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930584 ↗MalfunctionJul 28, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056741 ↗MalfunctionJul 7, 2026Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE ATTUNE CEMENTED DRILL AND DRILL TOWER BEGAN TO BIND DURING TIBIAL PREP. THE INSTRUMENTS WERE IMMEDIATELY REMOVED AND A NEW TRAY WAS OPENED. INSPECTION REVEALED SCORING ON BOTH INSTRUMENTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25737165 ↗MalfunctionApr 3, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DRILL TOWER AND TIBIAL DRILL DIDN¿T MEET WELL AND CREATED METAL FILINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776143 ↗MalfunctionMar 30, 2026Device-Device Incompatibility
THE INSTRUMENT IS SOMEHOW BROKEN/DAMAGED FROM THE BEGINNING (YOU HAVE TO FORCE THE DRILL INTO THE DRILL TOWER ¿ VERY STIFF AND DOESN¿T FIT) THIS IS THE INSTRUMENT SET THAT THEY STARTED TO USE LATER BECAUSE OF THE MISSING 4L FEMUR PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24717246 ↗MalfunctionDec 12, 2025Break; Break
IT WAS REPORTED THAT THE COLOR RING OF THE ATTUNE LTL CEM TIBIAL DRILL HAS COME LOOSE AND COMPROMISING STERILITY AND RAISING CONCERNS THAT FOREIGN MATERIAL COULD REMAIN IN THE PATIENT. THE PRODUCT WAS REMOVED FROM CIRCULATION AND PLACED IN QUARANTINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23793118 ↗MalfunctionSep 5, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BEARINGS ON PROXIMAL PART OF DRILL ARE BROKEN. THE RED DRILL STOP WOULD NOT "CLICK" ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22982509 ↗MalfunctionSep 5, 2025Break; Break
IT WAS REPORTED THAT METAL SHAVINGS WERE COMING OFF THE TIBIAL REAMER WHEN USED TO REAM THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22979777 ↗MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIBIA PREPARATION DRILL BLOCKER PIECE WAS FALLING OFF AND DID NOT GRAB THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518905 ↗MalfunctionFeb 20, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING TIBIAL PREPARATION, THE TIBIAL TOWER AND DRILL WAS USED, AND THE TOWER'S OPENING HAD SHRUNK/REDUCED RESULTING IN BURRING FROM THE DRILL UPON ACTION THROUGH THE TOWER OPENING TO THE TIBIA. THIS CAUSED METAL TO BE STRIPPED FROM THE DRILL, DAMAGING IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE FRAGMENTS THAT WERE GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21420391 ↗MalfunctionFeb 6, 2025Break; Material Discolored; Device-Device Incompatibility; Material Deformation; Break; Material Discolored; Device-Device Incompatibility; Material Deformation
DURING DRILLING OF THE FIXED BEARING TIBIA THE DRILL WAS NOT ABLE TO PASS THROUGH THE DRILL TOWER. THE SURGEON APPLIED PRESSURE BUT THE DRILL WOULD STILL NOT MAKE CONTACT WITH THE TIBIA. WHEN DRILL WAS REMOVED IT WAS REVEALED A BURR WITHIN THE TOWER WAS PREVENTING THE DRILL FROM PASSING THROUGH AND HAD DAMAGED THE DRILL. AN ALTERNATE SET WAS OPENED AND USED. SURGERY WAS DELAYED 2 MINUTES WHILE AN ALTERNATE SET WAS OPENED. PROCEDURE SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326841 ↗MalfunctionOct 21, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT PEG BROKE, NO EFFECT ON PATIENT. PEG RETRIEVED. 3/5 AND 6/8 STOPS WERE NOT STAYING IN PLACE. THERE WAS NO SURGICAL DELAY AND NO EFFECT ON SURGERY AND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493608 ↗MalfunctionOct 3, 2024Break; Break
IT WAS REPORTED THAT METAL IS CHIPPING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20360907 ↗MalfunctionSep 30, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334708 ↗MalfunctionJul 11, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ONE OF THE BALL BEARINGS HAS PUSHED INSIDE THE DRILL ITSELF, THIS MEANS THAT IT NO LONGER HOLD THE DRILL COLLAR IN PLACE. THIS DID NOT CAUSE AN ISSUE DURING SURGERY AND NO EFFECT TO THE PATIENT. THE INCIDENT DATE IS UNKNOWN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720317 ↗MalfunctionJun 18, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
THE BALL BEARING OF THE TIBIAL DRILL SEEM TO HAVE DROPPED INTO THE DRILL ITSELF, THEREFORE IT DOES NOT GRIP THE DRILL STOP PROPERLY. IT CAUSED LESS THAN 1 MINUTE DELAY TO SURGERY AND NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562584 ↗MalfunctionNov 2, 2023Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE RED STOPPER NO LONGER CLIPS INTO THE ATTUNE TIBIA DRILL AND NEEDS REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18056190 ↗MalfunctionMay 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL NO LONGER CONNECTS TO DRILL QUICK CONNECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032751 ↗MalfunctionMar 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOCKING SPLIT IN THE PROXIMAL PART OF THE DRILL IS MISSING. THIS WAS DISCOVERED DURING INSTRUMENT CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16636430 ↗MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL CREATED BURR MARK ON THE DRILL TOWER. DRILL WOULD NOT PASS SMOOTHLY THROUGH DRILL TOWER. NO INJURY OR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521069 ↗MalfunctionFeb 8, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE DRILL AND TOWER NO LONGER FIT PROPERLY TOGETHER. THERE IS A BURR ON THE DRILL THAT PREVENTS IT FROM SEATING. ADDITIONALLY, THE TOWER HAS BECOME TOO NARROW FOR THE DRILL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16328417 ↗MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RED DEPTH STOPPERS DO NOT STICK TO THE TOP OF THE DRILL. WHEN SOMEONE SLIDES THEM UP THE DRILL, THEY JUST FALL RIGHT OFF THE REAMER. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16131885 ↗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 16102046 ↗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 16102043 ↗MalfunctionDec 15, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TIBIAL DRILL CONNECTION DENTED AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993118 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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