ATTUNE 2546-00-415Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION SYSTEM HEX ATTACHMENT · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune hex attachment is a driver piece for the Attune knee revision system. Reports mostly describe the attachment seizing or cold-welding to handles or trial parts, with stripped threads, spinning, jamming or breaking. There are 25 reports naming its identifier, with no deaths and no injuries. No recalls name this device.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295451280), received between Jul 19, 2018 and Oct 21, 2025 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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
- Device-Device Incompatibility17
- Break5
- Material Deformation5
- Mechanical Jam4
- Material Twisted/Bent3
- Device Slipped1
- Difficult to Remove1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient7
- Insufficient Information3
- No Code Available1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PROPERLY FIX THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. THE THREADS OF THE TRIAL APPEAR TO BE COLD WELDED. TWO ADDITIONAL DEVICES WERE FOUND TO BE AFFECTED DURING ANALYSIS OF RETURNED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351428 ↗MalfunctionOct 21, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PROPERLY FIX THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. THE THREADS OF THE TRIAL APPEAR TO BE COLD WELDED. TWO ADDITIONAL DEVICES WERE FOUND TO BE AFFECTED DURING ANALYSIS OF RETURNED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349662 ↗MalfunctionMay 22, 2025Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT WHILE DISASSEMBLING THE HEX ATTACHMENT FROM THE BLACK HANDLE SCREWDRIVER, THE HEX ATTACHMENT WAS COLD WELDED ONTO THE BLACK HANDLE. THERE WAS NO PATIENT HARM, NO DELAY IN THE CASE. NOTHING BROKEN FROM THE TWO INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069625 ↗MalfunctionFeb 3, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT STAFF HAD A SCREW DRIVER HANDLE THAT WAS JUST SPINNING AND A DRIVER THAT WAS STRIPPED. THERE WAS NO DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295408 ↗MalfunctionOct 11, 2024Break; Break
IT WAS REPORTED THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427483 ↗MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLES ARE STUCK TOGETHER.
Patient problems: Insufficient Information
MAUDE report 20020854 ↗MalfunctionMar 18, 2024Break; Break
IT WAS REPORTED THAT HEX SCREWDRIVER WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920887 ↗MalfunctionFeb 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
BREAKAGE OF SMALL ATTUNE REVISION SCREWDRIVER. SHALT WONT DECOUPLE FROM HANDLE. NO DELAY IN SURGICAL TIME. NO ADVERSE IMPACT ON PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730513 ↗MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRIVER AND DRIVER HANDLE ARE STUCK TOGETHER, NO ADVERSE EVENTS NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18691279 ↗MalfunctionJan 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
BROKEN ATTUNE REVISION SCREWDRIVER AND HEX, STUCK IN FIXING WON¿T RELEASE NO DELAY ON SURGERY NOT BROKEN INTO TWO OR MORE PIECES NO IMPACT ON PATIENT LOT NUMBER UNKNOWN, NOT SUITABLE TO BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534647 ↗MalfunctionJan 12, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? THIS WAS FOUND "AFTER THE CASE". THERE WERE NO DETAILS ABOUT THE OPERATIVE PORTION OF THE PROCEDURE BECAUSE THE SCREWDRIVER PERFORMED NORMALLY DURING THAT TIME. IT WAS ONLY AFTER THAT THERE WAS AN ISSUE. B. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18501665 ↗MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER SHAFT WILL NOT DISENGAGE FROM HANDLE.
Patient problems: Insufficient Information
MAUDE report 18317684 ↗MalfunctionNov 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TORQUE WRENCH AND HEX SHAFT ARE STUCK TOGETHER AND CANNOT GET APART.
Patient problems: Insufficient Information
MAUDE report 18046116 ↗MalfunctionAug 9, 2023Break; Mechanical Jam; Naturally Worn; Break; Mechanical Jam; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SCREWDRIVER SHAFT WAS STUCK INTO THE TORQUE HANDLE, ALSO THE SCREWDRIVER TIP HAS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17491962 ↗MalfunctionMar 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT A SCREW THAT SHOULD COME APART WILL NOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16547439 ↗MalfunctionMar 14, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW DRIVER STUCK TOGETHER. IT WAS DAMAGED DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16539466 ↗MalfunctionJun 2, 2021Material Deformation; Material Deformation
ITEMS DAMAGED: THIS WAS DISCOVERED UPON OPENING THE DEMO SET PRIOR TO TRAINING. THE 4MM OFFSET GUIDE BECAME CROSS THREADED IN ONE OF THE FE GUIDES, THE HEX ATTACHMENT (1.3) WAS BENT AS THIS WAS ATTEMPTED TO BE UNSCREWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920507 ↗MalfunctionMar 11, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THEY HAD A SUCCESSFUL ATTUNE REVISION IMPLANT SURGERY. WHEN I CAME BACK TO THE HOSPITAL THE NEXT DAY, TO PUT INSTRUMENTS BACK IN THEIR TRAYS, I WAS HAVING TROUBLE WITH ONE. I AM NOT SURE WHY OR HOW IT HAPPENED BUT THE HEX DRIVER IS STUCK IN THE TORQUE HANDLE. THEY CANNOT BE SEPARATED. THEY WERE WORKING CORRECTLY DURING THE PROCEDURE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11465637 ↗MalfunctionAug 28, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE HEX HEAD OF SCREWDRIVERS ARE ROUNDED AND NOT HOLDING THE SCREWS WELL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10466524 ↗MalfunctionAug 28, 2020Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE HEX HEAD OF SCREWDRIVERS ARE ROUNDED AND NOT HOLDING THE SCREWS WELL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10466496 ↗MalfunctionJul 24, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE SCREWDRIVER AND HEX DRIVER ARE STUCK TOGETHER SOMEHOW AND WONT DISASSEMBLE. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10318361 ↗MalfunctionMar 12, 2020Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Unintended Movement; Physical Resistance/Sticking; Device Slipped; Device-Device Incompatibility; Material Twisted/Bent; Unintended Movement; Physical Resistance/Sticking
IT WAS REPORTED THAT THE HEX DRIVER AND HANDLE WILL NOT SEPARATE. THE HEX DRIVER FREELY SPINS IN HANDLE, THE HANDLE IS STRIPPED OUT. BOTH INSTRUMENTS NEED RAPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9827722 ↗MalfunctionMar 2, 2020Difficult to Remove; Device-Device Incompatibility; Mechanical Jam; Difficult to Remove; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE TORQUE SCREW DRIVER AND HANDLE BECAME LODGED TOGETHER AND WON¿T COME APART. IT DIDN¿T DELAY THE SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9775992 ↗MalfunctionJul 20, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW INSIDE TIBIAL TRIAL STRIPPED OUT. HEAD TO SCREWDRIVER ROUNDED OFF. CAN'T GET SCREW OUT OF TIBIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7706007 ↗MalfunctionJul 19, 2018Break; Break
IT WAS REPORTED THAT THIS PART WERE BROKEN DURING A CADAVER LAB TRAINING ON (B)(6) 2018. RECEIVED BROKEN PART FROM WAREHOUSE ON 06/26/2018. THE 2 PARTS JAMMED TOGETHER AND CANNOT SEPARATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7704690 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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