ATTUNE 2546-00-411Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION AUGMENT WOBBLE BIT · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune knee system wobble bit is the hex screwdriver used to fasten revision augments during knee replacement surgery. The 37 reports mostly describe the tool breaking — the tip or head snapping off while it was being used to tighten the augment, with the bit sometimes breaking inside the implant; in the reports that describe it, all pieces were retrieved. No deaths and no injuries were reported. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295440376), received between Jul 11, 2018 and May 13, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Break” (35 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
- Break35
- Adverse Event Without Identified Device or Use Problem1
- Illegible Information1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information6
- No Consequences Or Impact To Patient4
- Not Applicable3
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT DURING KNEE SURGERY, THE HEX DRIVER BROKE IN THE AUGMENT WHILE IT WAS BEING USED TO SCREW THE AUGMENT TO THE IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159854 ↗MalfunctionFeb 8, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE KNEE IT WAS OBSERVED THAT THE TIP OF HEX BROKE OFF WHILE PUTTING ON AUGMENT IMPLANTS. IT WAS REPORTED THAT ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288231 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT PRIOR TO AN ARTHROPLASTY SURGICAL PROCEDURE, THE TIP OF THE WOBBLE BIT SCREW DRIVER FELL ONTO THE FLOOR AND THE HEAD BROKE AND WAS UNABLE TO BE USED. THIS HAPPENED BEFORE THE PATIENT WAS BROUGHT INTO THE OR ROOM. ANOTHER SCREWDRIVER WAS RETRIEVED FROM AN ADDITIONAL SET AND THE CASE PROCEEDED SMOOTHLY WITHOUT ISSUE. IF OTHER, DESCRIBE TOTAL KNEE REVISION, DID THE EVENT OCCUR DURING STERILE PROCESSING? NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, 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 NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067588 ↗MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER HEAD WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903560 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE. ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786893 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE WOBBLE END SCREWDRIVER BROKE WHILE TIGHTENING AUGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142592 ↗MalfunctionApr 25, 2025Break; Illegible Information; Break; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21911049 ↗MalfunctionSep 25, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO ADVERSE EVENT AND NO SURGICAL DELAY. ALL BROKEN PIECES WERE ACCOUNTED FOR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20300288 ↗MalfunctionJun 6, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475210 ↗MalfunctionFeb 20, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKE DURING IMPLANT ASSEMBLY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737894 ↗MalfunctionSep 6, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE REVISION AUGMENT WOBBLE BIT DRIVER TIP BROKE OFF WHILE ASSEMBLING IMPLANTS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17692574 ↗MalfunctionApr 10, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6)2023, THE PRODUCT IN QUESTION WAS USED FOR TKA PREFORMED FOR OA ON THE RIGHT. AN 8 MM AUGMENTATION WAS USED ON THE POSTERIOR CONDYLE DUE TO A LARGE CYST IN THE POSTERIOR CONDYLE. DURING THE SURGERY, THE TIP OF A SCREWDRIVER WAS BROKEN DURING ASSEMBLY OF THE IMPLANT. SINCE THE 8 MM AUGMENTATION WAS CONFIRMED TO BE FIXED, IT WAS USED AS IS AT THE SURGEON'S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16707479 ↗MalfunctionMar 27, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EFFECT ON OUTCOME. THE INSTRUMENT BROKE IN HALF, NOT STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618885 ↗MalfunctionJan 11, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA WITH COMPETITOR'S IMPLANTS. AFTER THE SURGERY, THE REVISION SURGERY WAS DONE WITH ATTUNE REVISION IMPLANTS ON (B)(6) 2022, FOR UNKNOWN REASON. IN THE REVISION SURGERY, THE AUGMENT WOBBLE BIT IN QUESTION BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING AN AO DRIVER OWNED BY THE HOSPITAL WITHIN 30 MINUTES SURGICAL DELAY. THERE IS NO PROBLEM IN THE METHOD OF USE BY THE SURGEON WHEN ASSEMBLING IMPLANTS, AND IT SEEMS TO HAVE BEEN DAMAGED DUE TO AGING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16137441 ↗MalfunctionDec 19, 2022Break; Break
IT WAS REPORTED THAT THE HEX TIP OF WOBBLE WRENCH BROKE OFF. NOTICED IT WHEN OPENING THE TRAYS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16008314 ↗MalfunctionOct 19, 2022Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIP BROKE INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15632198 ↗MalfunctionJul 28, 2022Break; Break
IT WAS REPORTED THAT THE AUGMENT WOBBLE BIT BROKE WHILE ATTACHING THE FINAL AUGMENT. THE AUGMENT WAS WELL FIXED. THE BROKEN PIECE WAS RECOVERED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15121958 ↗MalfunctionJun 6, 2022Break; Break
THE TIP OF ATTUNE REVISION AUGMENT SCREWDRIVER BROKE OFF WHILE SCREWING FINAL AUGMENT TO REVISION FEMUR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14602346 ↗MalfunctionMar 14, 2022Break; Break
IT WAS REPORTED THAT THE TIP OF INSTRUMENT BROKE OFF DURING IMPLANTATION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13757575 ↗MalfunctionMar 10, 2022Break; Break
IT WAS REPORTED THAT THE AUGMENT WOBBLE BIT TIP BROKE INTO TWO PIECES WHILE TRYING TO SECURE AUGMENTS. THERE WAS A SURGICAL DELAY OF ONLY A FEW MINUTES.
Patient problems: Insufficient Information
MAUDE report 13719866 ↗MalfunctionNov 21, 2021Break; Break
TIGHTENING END OF AUGMENT WOBBLE BIT HAS SNAPPED OFF. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12850208 ↗MalfunctionSep 21, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HEX HEAD BROKE IN 1 PIECE. THERE WAS A 5 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12509452 ↗MalfunctionSep 13, 2021Break; Break
COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE TIP OF THE AUGMENT WOBBLE BIT BROKE AS THE SURGEON WAS PUTTING THE AUGMENTS ON THE BACK OF THE FEMUR. THEY COMPLETED THE CASE BY OPENING UP A DIFFERENT SCREW DRIVER BIT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12460562 ↗MalfunctionJul 22, 2021Break; Break
DURING A SURGERY WITH ATTUNE REVISION COD 2546-00-411 BROKE INTO TWO PIECES WHILE ASSEMBLING THE FEMORAL AUGMENTS. SURGERY WAS DELAYED 5 MINUTES WHILE THE SURGEON FOUND A LIKE SCREWDRIVER TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 12211223 ↗MalfunctionJul 15, 2021Break; Break
IT WAS REPORTED THAT THE HEX TIP SNAPPED INTO TWO PIECES. NO PIECES WENT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12173769 ↗
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 13, 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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