ATTUNE 2545-00-065Recalls & reported problems
Depuy (Ireland) · ATTUNE PIN IMPACTOR · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295130628), received between Dec 20, 2019 and Jun 17, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 Incompatibility3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE PIN IMPACTORS AREN¿T SUCCESSFULLY GRASPING ONTO THE PINS LEADING TO MULTIPLE PINS FALLING OFF. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537990 ↗MalfunctionJun 17, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE PIN IMPACTORS AREN¿T SUCCESSFULLY GRASPING ONTO THE PINS LEADING TO MULTIPLE PINS FALLING OFF. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537985 ↗MalfunctionJun 17, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE PIN IMPACTORS AREN¿T SUCCESSFULLY GRASPING ONTO THE PINS LEADING TO MULTIPLE PINS FALLING OFF. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25537984 ↗MalfunctionNov 8, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12773627 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE TRIAL EXTRACTOR "SPATULA" TIP BROKE OFF WHEN REMOVING TRIAL ARTICULATING SHIM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9504937 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page