ATTUNE 2545-00-166Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIAL DRILL STOP SIZE 6-8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295422532), received between Jun 26, 2019 and Apr 23, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Device-Device Incompatibility2
- Corroded1
- Crack1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information3
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Break; Crack
IT WAS REPORTED THAT WHEN TAKING THE 8MM SHIM OFF THE DOG BONE THE SHIM BROKE IN HALF DUE TO A CRACK ALREADY BEING ON THERE. THE DRILL STOPPED AND ALSO HAD A CRACK AND BROKE WHEN TOO MUCH FORCE WAS APPLIED TO THE DRILL FOR THE TIBIA. BOTH BROKEN PIECES WERE THROWN AWAY BY STERILE PROCESSING (SPD) BEFORE WE COULD RETRIEVE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971655 ↗MalfunctionFeb 17, 2026Break
BROKEN KNEE INSTRUMENTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367070 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21529958 ↗MalfunctionMar 5, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21529957 ↗MalfunctionFeb 3, 2025Break; Corroded; Break; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPING AND PITTED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21297706 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT WHEN ASSEMBLING TRAYS, THE INSTRUMENT WAS FOUND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21111545 ↗MalfunctionSep 10, 2024Break; Break
IT WAS REPORTED THAT THE ATTUNE 6-8 DRILL STOP BROKE INTO 2 PIECES DURING THE SURGERY. BOTH PIECES FELL TO THE FLOOR, NOT AFFECTING THE PATIENT. SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180665 ↗MalfunctionNov 20, 2023Break; Break
IT WAS REPORTED THAT THE KNEE INSTRUMENTS BROKE DURING THE SURGERY. THEY BOTH NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170576 ↗MalfunctionJan 18, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16195994 ↗MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 6-8 DEPTH STOP, NO LONGER ATTACHES TO THE TIBIAL DRILL. WHEN ATTACHED IT DOES NOT STICK, IT JUST CONTINUES TO SLIDE DOWN THE TIBIAL DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16132008 ↗MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE POST WAS MISSHAPED AT THE TOP AND NOT HOLDING TRIALS. THE PIN DRIVER WAS NOT ALLOWING PINS TO COME OFF EASILY, 6/8 DRILL STOP WAS NOT STAYING ON THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912739 ↗MalfunctionSep 17, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE TAB ON THE DRILL STOP BENT AND NO LONGER LATCHES TO DRILL. SURGICAL DELAY.
Patient problems: No Code Available
MAUDE report 10546708 ↗MalfunctionFeb 12, 2020Break; Break
IT WAS REPORTED THAT THE CLIP BROKE OFF OF THE 6-8 DEPTH STOP AND THE IMPACTORS ARE ALL CRACKED AND HEADING TOWARDS BREAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9702042 ↗MalfunctionJun 26, 2019Break; Break
IT WAS REPORTED THAT THE IMPACTOR HANDLE BROKE WHILE IMPACTING FEMUR. IMPACTOR TIPS ARE CRACKED AND COMPROMISED. DEPTH STOP CRACKED AND WON'T HOLD. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736251 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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