ATTUNE 2546-00-418Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM ATTUNE REVISION BROACH HANDLE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune revision broach handle is a surgical handle used with knee replacement instruments. Many of the 125 reports describe handles that did not lock or hold broaches in place, and some describe broken or stripped parts. The reports include no deaths and 3 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
- 129
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10603295475910), received between Jun 15, 2018 and Sep 25, 2026 — classified as 3 injuries, 126 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (87 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 Incompatibility87
- Break11
- Connection Problem11
- Unintended Movement8
- Appropriate Device Problem Term/Code Not Available5
- Naturally Worn5
- Device Handling Problem4
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Not Applicable36
- No Consequences Or Impact To Patient26
- No Code Available25
- Insufficient Information8
- Bone Fracture(s)2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that broach handles were worn and do not connect properly to femoral broaches anymore. This did not occur during surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899721 ↗MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that broach handles were worn and do not connect properly to femoral broaches anymore. This did not occur during surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899696 ↗MalfunctionSep 21, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847572 ↗MalfunctionSep 21, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847569 ↗MalfunctionApr 13, 2026Contamination /Decontamination Problem
DIRTY ITEMS AND MISSING ITEMS IN ORTHOKIT MODULE. NO IMPACT ON SURGERY OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865265 ↗MalfunctionMar 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE THE BOLTS WERE STRIPPED AND THE BROACH HANDLES DID NOT LOCK BROACH IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699740 ↗MalfunctionMar 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE BOLTS WERE STRIPPED AND THE BROACH HANDLES DID NOT LOCK BROACH IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699601 ↗MalfunctionFeb 3, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE REVISION KNEE FEMORAL BROACH HANDLE WAS NOT LOCKING ON TO THE BROACHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252012 ↗MalfunctionNov 20, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT HANDLE WAS LOOSE, NOT HOLDING BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23607645 ↗MalfunctionNov 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS LOOSE. IT WILL NOT HOLD BROACHES PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573179 ↗MalfunctionJun 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BROACH HANDLE DIDN'T STAY LATCHED. 6MM HEX TIP WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22347468 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT THE LEVER GOT JAMMED OF ATTUNE FEMORAL IMP/EXTR AND THE BASE SNAPPED OFF FROM THE BROACH HANDLE. THE PRODUCT DAMAGE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985668 ↗MalfunctionMar 31, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE BROACH HANDLE LATCH WAS LOOSE AND WOULDN¿T STAY SHUT WHICH CAUSED THE BROACH TO COME OFF THE HANDLE. THIS DID NOT SLOW DOWN THE PROCEDURE SINCE THE OTHER BROACH HANDLE WAS USED AND THE SURGERY PROCEEDED AS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730746 ↗MalfunctionMar 27, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY, AND THE HANDLE WAS LOOSE AND WOULD NOT SECURE BROACH.
Patient problems: Insufficient Information
MAUDE report 21706093 ↗MalfunctionAug 8, 2024Break; Break
THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TRIAL IS DAMAGED CLOSE TO THE STAB. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19937547 ↗MalfunctionJul 24, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH HANDLE WOULD NO LONGER ENGAGE BROACH TO REMOVE. NO HARM TO PATENT AND NO SURGERY DELAY. NO BROKEN PIECES, HANDLE IS INTACT AND NO INSTRUMENT LEFT IN PATIENT, NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819191 ↗MalfunctionJun 25, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE RIGHT TOTAL ATTUNE KNEE WITH A TIBIAL TRAY THAT HAD FALLEN INTO SEVERE VARUS. THE TIBIAL TRAY WAS REVISED, AND THE FEMUR AND PATELLA WERE WELL FIXED AND RETAINED. THE TRAY DID NOT HAVE ANY CEMENT STUCK TO IT'S BACKSIDE. DURING BROACHING OF THE TIBIA, THE TIBIAL BROACH HANDLE BROKE. ALL PIECES WERE FOUND. DOI: (B)(6) 2017 DOR: (B)(6)2024 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 19604158 ↗MalfunctionJun 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS NOT GRIPPING BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19516175 ↗MalfunctionJan 22, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE BROACH HANDLE WAS DAMAGED. VISUAL EXAM FOUND HANDLE WAS BROKEN AROUND THE IMPACTION AREA. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552278 ↗MalfunctionJan 4, 2024Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close
IT WAS REPORTED THAT THE BROACH HANDLE WON¿T OPEN TO ACCEPT BROACH.
Patient problems: Insufficient Information
MAUDE report 18442704 ↗MalfunctionOct 18, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE REV BROACH HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17959502 ↗MalfunctionApr 25, 2023Break; Break
IT WAS REPORTED THE STRIKE PLATE FROM THE ATTUNE REVISION BROACH HANDLE BROKE OFF. NO SURGICAL DELAY, NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811154 ↗MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility
DARTMOUTH WAS AN EARLY EVALUATOR FOR ATTUNE REVISION. THE BROACH HANDLES DON'T GRAB. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16198324 ↗MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility
DARTMOUTH WAS AN EARLY EVALUATOR FOR ATTUNE REVISION. THE BROACH HANDLES DON'T GRAB. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16198275 ↗MalfunctionJan 18, 2023Device-Device Incompatibility; Device-Device Incompatibility
DARTMOUTH WAS AN EARLY EVALUATOR FOR ATTUNE REVISION. THE BROACH HANDLES DON'T GRAB. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16198190 ↗
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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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