ATTUNE 2546-00-420Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION IMPLANT ASSEMBLY WRENCH · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE revision implant assembly wrench is a surgical instrument used to tighten and assemble knee implant parts. The 31 reports mostly describe the tool breaking, screws coming loose or falling out and being lost, and metal pieces detaching or bending so the wrench would not tighten properly. No deaths or injuries are described, and surgeries were completed in most cases. There are no recalls naming 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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295440338), received between Apr 4, 2019 and May 13, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Detachment of Device or Device Component8
- Device-Device Incompatibility4
- Material Deformation4
- Unintended Movement2
- Calibration Problem1
- Component Missing1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information6
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. SCREWS FELL OUT OF IT AND WERE LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163828 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE TORQUE GAUGE WINDOW CAME OFF OF THE WRENCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505350 ↗MalfunctionNov 20, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIAL POST WAS BROKEN, THE WRENCH ROD FOR TORQ WAS BENT AND WOULD NOT TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609103 ↗MalfunctionNov 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
DURING THE PROCEDURE, IT WAS EVIDENT THAT THE ASSEMBLY WRENCH WAS MISSING A SCREW. IT ALSO OCCURRED THAT WHILE WE WERE HOLDING THE TIBIA TO TIGHTEN THE STEM, THE OFFSET ASSEMBLY STABILIZER BROKE, PREVENTING THE SURGICAL TEAM FROM ASSEMBLING THE OFFSET. THEY ATTEMPTED TO ASSEMBLE IT WITH ONE PERSON HOLDING IT, RESPECTING THE OFFSET DIRECTION, BUT THIS WAS NOT POSSIBLE BECAUSE IT ROTATED. TO RESOLVE THIS, THE DOCTOR, AFTER SEVERAL ATTEMPTS, DECIDED TO USE MORE REAMER AND BYPASS THE OFFSET, THEN TIGHTEN IT MANUALLY OUTSIDE THE ASSEMBLY. THIS ALLOWED FOR SUCCESSFUL COMPLETION OF THE SURGERY WITHOUT AFFECTING THE PATIENT. IT CAUSED A DELAY OF APPROXIMATELY THIRTY MINUTES.
Patient problems: Insufficient Information
MAUDE report 23511107 ↗MalfunctionOct 24, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DURING THE SURGERY AT THE TIME OF MAKING THE ASSEMBLY AND ASSEMBLY OF THE ATTUNE IMPLANT IT IS EVIDENT THAT THIS KEY WAS DETACHED IN ITS BASE AND ALSO IT IS NECESSARY A SCREW. FOR THIS NOVELTY THERE WERE NO DISCOMFORT ON THE PART OF THE SPECIALIST SINCE IT WAS POSSIBLE TO WORK WITH THIS INSTRUMENT DURING THE PROCEDURE, THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377948 ↗MalfunctionOct 21, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE. PRIOR TO THE PROCEDURE, THE STEM WRENCH IN THE ASSEMBLY REVISION TRAY WAS DAMAGED WHEN THE TRAY WAS OPENED. THE METAL PIECE ATTACHED IN THE MIDDLE OF THE SHAFT - JUST AFTER THE GRAY HANDLE, WITH THE MARKINGS H-H, APPEARED TO BE DETACHED FROM THE SHAFT AND MOVING WHILE IT SHOULD NOT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350687 ↗MalfunctionJun 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE ATTUNE REV IMPLANT ASSEMBLY WRENCH WOULD NOT SCREWED IN. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22359909 ↗MalfunctionMay 14, 2025Break; Break
IT WAS REPORTED THAT WHILE PUTTING INSTRUMENTS TOGETHER, IT WAS NOTICED THAT THE WRENCH HANDLE WAS MISSING THE METAL PART THAT LETS THE USER KNOW WHEN IT'S TORQUED PROPERLY. IT IS UNKNOWN WHEN IT BROKE OFF. NO HARM TO PATIENT. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022239 ↗MalfunctionMay 5, 2025Calibration Problem; Device-Device Incompatibility; Calibration Problem; Device-Device Incompatibility
IT WAS REPORTED THAT THE ASSEMBLY WRENCH HAD A SCREW BACK OUT OF THE TORQUE PLATE AND WILL NOT PROPERLY GAUGE THE TORQUE BEING PUT ON THE WRENCH. ALL PIECES WERE RETRIEVED AND THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962273 ↗MalfunctionFeb 20, 2025Break; Break
IT WAS REPORTED THAT TORQUE WRENCH INDICATOR BROKE OFF FROM THE WRENCH. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423998 ↗MalfunctionFeb 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED WHEN APPLYING TORQUE TO THE STEM OF THE FEMORAL COMPONENT, THE PIECE IS DAMAGED, AND THE ASSEMBLY KEY IS ALSO SEEN ROLLING IN ITS HEXAGON, WHICH COULD ALTER THE FIXATION OF THE STEM.
Patient problems: Insufficient Information
MAUDE report 21306901 ↗MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, THE SCREWS IN THE ATTUNE REVISION ASSEMBLY WRENCH FELL OUT. THEY WERE FOUND IMMEDIATELY. HOWEVER, THE TENSIONING PORTION OF THE ASSEMBLY WRENCH WAS NO LONGER ATTACHED, SO IT COULD NOT BE USED TO VERIFY THE TIGHTNESS OF THE STEM.
Patient problems: Insufficient Information
MAUDE report 20682756 ↗MalfunctionSep 5, 2024Break; Break
IT WAS REPORTED THAT UPON INSPECTION THE ATTUNE ASSEMBLY WRENCH IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150969 ↗MalfunctionAug 14, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HANDLE IS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982572 ↗MalfunctionAug 6, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT TENSOR IS BENT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917476 ↗MalfunctionMay 9, 2024Break; Break
IT WAS REPORTED THAT THE SET SCREW HOLDING THE TORQUE GAUGE BROKE.
Patient problems: Insufficient Information
MAUDE report 19276806 ↗MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON NOTED THAT SET SCREW WAS MISSING ON TORQUE WRENCH. IT CAUSED NO ISSUE IN THE CASE AND JUST NEEDED TO BE FIXED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19234448 ↗MalfunctionFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCREW FOR THE TIGHTENER FELL OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18641855 ↗MalfunctionOct 30, 2023Break; Break
IT WAS REPORTED THAT TORQUE GAUGE BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 18029075 ↗MalfunctionOct 5, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN GOING TO USE THIS INSTRUMENT, IT WAS NOTICED THERE WAS A SCREW MISSING. IT IS BELIEVED THAT THE SCREW FELL OUT BEFORE THE CASE, DURING DECONTAMINATION. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17879521 ↗MalfunctionMay 30, 2023Break; Break
IT WAS REPORTED THAT GAUGE IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 17021224 ↗MalfunctionMay 8, 2023Break; Break
IT WAS REPORTED THAT THE IMPLANT ASSEMBLY WRENCH BROKE WHILE ASSEMBLING THE TIBIAL IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888181 ↗MalfunctionMay 5, 2023Break; Break
IT WAS REPORTED THAT A SCREW FELL OUT FROM THE TORQUE INDICATING PLATE OF THE ATTUNE ASSEMBLY WRENCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876203 ↗MalfunctionOct 20, 2022Break; Break
IT WAS REPORTED THAT THAT THE INSTRUMENTS WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638485 ↗MalfunctionSep 7, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE NEEDLE OF AN INSTRUMENT WAS BENT AND NEEDS REPLACING, THIS NEEDLE SHOWS THE APPROPRIATE FORCE TO LOCK THE STEM ONTO THE TIBIAL PLATE. NO PATIENT HARM. NO XRAYS NEEDED. NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15369880 ↗
Other WRENCH devices
- MONARCH 277040510Medos International Sàrl · WRENCH199 reports
- PINNACLE 2217-50-008Depuy (Ireland) · WRENCH108 reports
- SIGMA 96-1673Depuy (Ireland) · WRENCH102 reports
- P.F.C. 86-5189Depuy (Ireland) · WRENCH92 reports
- Veptr 03.641.004Synthes GmbH · WRENCH86 reports
- RECLAIM 2975-00-300Depuy (Ireland) · WRENCH51 reports
- PINNACLE 2217-50-006Depuy (Ireland) · WRENCH34 reports
- NA 388.261Synthes GmbH · WRENCH32 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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