ATTUNE 2544-00-502Recalls & reported problems
Depuy (Ireland) · ATTUNE INTRA-MEDULLARY ROD · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE intra-medullary rod is a surgical alignment rod used during knee replacement surgery. The 31 reports mostly describe the rod or its handle breaking or cracking during surgery or while being reprocessed, with parts sometimes needing to be retrieved from the patient, and alignment guides shifting during pin insertion. No deaths and no injuries were reported, and most cases describe no lasting harm. No recalls name this device, and reports have dropped from 5 in the prior12 months to 1 in the past year.
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 10603295130024), received between Mar 1, 2018 and Sep 18, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
- Break22
- Crack4
- Detachment of Device or Device Component2
- Device-Device Incompatibility2
- Manufacturing, Packaging or Shipping Problem1
- Material Deformation1
- Material Integrity Problem1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient9
- Insufficient Information3
- No Code Available3
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
It was reported that there was a broken instrument from primary attune set - Attune distal femur jig handle snapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819192 ↗MalfunctionOct 24, 2025Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A GASH IN INTRAMEDULLARY T-HANDLE. STERILE PROCESSING DEPARTMENT CANNOT PROCESS IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379065 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT THE SURGEON BROKE THE END OF THE IM ROD IMPACTING DISTAL FEMORAL JIG INTO KNEE. NO TIME WAS EXTENDED AND THE PATIENT WASN'T AFFECTED. IT WAS BROKE INTO TWO PIECES AND BOTH PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329713 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT THE ROD HANDLE BROKE OFF MID CASE. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997485 ↗MalfunctionMay 6, 2025Crack; Crack
IT WAS REPORTED THAT THE PATELLA CLAMP WOULD NOT CLAMP IN PLACE. HAD TO MANUALLY HOLD WHILE PATELLA CEMENT CURED. GREY HANDLED IM ROD HAS A CRACK IN THE HANDLE.
Patient problems: Insufficient Information
MAUDE report 21971778 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS DUE TO OVER USE. THE ITEMS ARE NO LONGER ABLE TO BE IN CIRCULATION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159811 ↗MalfunctionOct 9, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE FEMORAL ALIGNMENT ROD HAD A SCRATCH IN IT THAT THE STERILE PROCESSING DEPARTMENT PERSON STATED IS NO LONGER ABLE TO BE USED IN CASES. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT DEVICE PRESENTS SIGNS OF WORN.
Patient problems: Insufficient Information
MAUDE report 20410686 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THAT THE ATTUNE FEMORAL ROD WAS BROKEN DURING SURGERY. ALL PIECES WERE RECOVERED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651149 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED BY SPD DUE TO BROKEN PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159181 ↗MalfunctionNov 14, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DISTAL FEMORAL RESECTION GUIDE WAS PLACED INTO THE FEMORAL CANAL AND THE CUTTING BLOCK WAS PINNED, SURGEON WENT TO REMOVE THE INTRAMEDULLARY ROD AND IT BECAME LODGED IN THE CANAL. NO PARTS WERE BROKEN OFF, THE CASE WAS DELAYED APPROXIMATELY 10 MINS BUT THERE WAS NO HARM TO THE PATIENT AND ALL PARTS OF THE INSTRUMENT WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18131564 ↗MalfunctionOct 5, 2023Break; Break
IT WAS REPORTED THAT THE T HANDLE BROKE OFF FROM IM ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17875914 ↗MalfunctionSep 6, 2023Break; Break
NURSE REPORTED BROKEN ATTUNE INSTRUMENT WHICH REQUIRES REPLACEMENT. SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689625 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT AFTER CASE WAS FINISHED, THE IM ROD WENT THROUGH THE CLEANING PROCESS AND SPD, THE INSTRUMENT CAME OUT BROKEN. IT WAS BELIEVED THE INCIDENT OCCURRED WHEN IT WENT THROUGH THE WASH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16975327 ↗MalfunctionMay 9, 2023Break; Break
IT WAS REPORTED THAT THE ROD BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16898419 ↗MalfunctionOct 21, 2022Break; Break
IT WAS REPORTED THAT IN THE DISTRIBUTION CENTER, THE SALES REPRESENTATIVE NOTICED THAT THESE INSTRUMENTS WERE BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649619 ↗MalfunctionOct 19, 2022Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635130 ↗MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HOLDING METAL BUSHING ON IM ROD WASN¿T PRESENT. SALES REP NOTICED HE PUT THE INCORRECT PART NUMBER ON THIS ITEM. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15549793 ↗MalfunctionFeb 18, 2022Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE BROKEN INSTRUMENTS (WEAR AND TEAR) NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559855 ↗MalfunctionSep 23, 2021Break; Break
IT WAS REPORTED THAT THE FEMORAL ALIGNMENT ROD HANDLE WAS BROKE OFF DURING AN ATTEMPT TO REMOVE THE ROD FROM THE FEMORAL CANAL AFTER IT HAD BECAME STUCK IN THE FEMUR PRIOR TO DISTAL FEMORAL RESECTION. ALL PIECES ARE ACCOUNTED FOR AND BEING SENT BACK TO DISTRIBUTOR, THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT WAS NOT HARMED, BOTH PIECES WERE REMOVED FROM THE STERILE FIELD IMMEDIATELY. I DO NOT HAVE ANY FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12518807 ↗MalfunctionApr 28, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DISTAL GUIDE DOES NOT LOCK ONTO IM ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739022 ↗MalfunctionFeb 3, 2021Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HANDLE BROKE OFF OF THE ROD INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11275766 ↗MalfunctionJan 27, 2021Break; Break
IT WAS REPORTED THAT THE IM ROD BROKE NEAR HANDLE WHEN INSERTED IN FEMUR. ALL PIECES RECOVERED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11238077 ↗MalfunctionOct 12, 2020Crack; Crack
IT WAS REPORTED THAT THEY NOTICED CRACK IN INSTRUMENT, UNSURE OF WHEN IT OCCURRED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10666548 ↗MalfunctionSep 16, 2020Break; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem; Break; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem
HAS PRODUCT BEEN POTENTIALLY CONTAMINATED OR IS CONTAMINATED WITH BODILY FLUIDS? YES 2545-00-928 HAS A CRACK THAT WAS DISCOVERED DURING CLEANING/STEAM STERILIZATION. 2545-01-969 HAS BROKEN INTO 2 PIECES THAT HAPPENED PER-OP. 2544-00-502 A PIECE OF PLASTIC FELL OFF DURING USE PER-OPERATIVE. WHERE / WHEN DID THE EVENT OCCUR? INTRA - OP, POST - OP. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10541471 ↗MalfunctionJul 24, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE IM ROD HAS AN EDGE ON IT THAT DOESN¿T ALLOW IT TO ENGAGE CORRECTLY INTO THE JIG FOR THE DISTAL FEMORAL CUT. NO SURGICAL DELAY REPORTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10321588 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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