ATTUNE 2545-00-163Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIAL DRILL STOP SIZE 3-5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295422525), received between Apr 25, 2018 and Aug 5, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Device-Device Incompatibility9
- Detachment of Device or Device Component1
- Illegible Information1
- Naturally Worn1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Consequences Or Impact To Patient4
- Insufficient Information2
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139523 ↗MalfunctionJan 7, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL STOP WOULD NOT CLICK ONTO THE BEARINGS. THE OTHER DRILL STOPPED WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990330 ↗MalfunctionNov 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT WOULD NOT SNAP ON THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630354 ↗MalfunctionJul 28, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT RED RING SLIPS OFF TOO EASY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22636579 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN AFTER USE DURING A TOTAL KNEE REPLACEMENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 21925148 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT A SIZE 3-5 DRILL STOP FOR THE TIBIAL DRILL WAS FOUND BROKEN WHEN THE TRAY WAS OPENED FOR A PROCEDURE. THE PIECE THAT HAS BEEN BROKEN OFF THE DRILL WAS NOT IN THE TRAY. THE SURGEON USED THE TIBIAL DRILL WITHOUT THE DRILL STOP, USING THE LINES MARKED ON THE DRILL TO GUIDE DEPTH. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752469 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515122 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514963 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE PIECES HAVE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19700401 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PINS WERE USED AND AFTER THEY CAME OUT OF THE WASH, THESE WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552628 ↗MalfunctionJan 19, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
ATTUNE DRILL STOP HAS BECOME LOOSE AND IS NO LONGER GRIPPING THE DRILL. IT CAUSED NO IMPACT TO SURGERY OR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18548027 ↗MalfunctionSep 22, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17799041 ↗MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RED 3-5 DRILL STOP WON¿T CLICK INTO THE REAMER. SO IT WOULD FALL AS WE REAMED. THEY DISCARDED THE RING. NO DELAYED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060061 ↗MalfunctionMar 21, 2023Device-Device Incompatibility; Naturally Worn; Illegible Information; Device-Device Incompatibility; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THE RED DRILL STOP DOESN'T STAY ON THE DRILL BIT. IT IS NOT BROKEN INTO PIECES, AND NO INSTRUMENT OR INSTRUMENT PARTS WERE LEFT IN THE PATIENT. ALL INSTRUMENTS WERE REMOVED FROM THE PATIENT. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16582733 ↗MalfunctionFeb 16, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY. IN THE SURGERY, THE ENGAGEMENT BETWEEN THE ATTUNE TIBIAL DRILL TOWER IN QUESTION AND THE ATTUNE TIBIAL DRILL IN QUESTION WAS NOT GOOD. SO, REAMING OVER THE TOWER WAS NOT POSSIBLE, SO THE SURGEON REAMED MANUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16386866 ↗MalfunctionJan 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 3-5 DEPTH STOP, NO LONGER ATTACHES TO THE TOP OF THE REAMER. THIS WAS SHOWN BY THE SCRUB TECH PRIOR TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137228 ↗MalfunctionJun 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL STOP WAS NOT SECURELY FITTING ON DRILL. NO PIECES WERE BROKE OFF OF DRILL STOP. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12041771 ↗MalfunctionMay 19, 2021Break; Break
ATTUNE 3-5 DRILL STOP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11851910 ↗MalfunctionJul 14, 2020Break; Break
IT WAS REPORTED THAT THE 3-5 TIBIA DEPTH STOP ATTACHMENT ARM BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10272285 ↗MalfunctionMay 15, 2020Break; Break
IT WAS REPORTED THAT THE 3-5 DEPTH STOP CLIP BROKE OFF AND THE FEMUR AND TIBIA IMPACTORS ARE CRACKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10061757 ↗MalfunctionDec 12, 2019Break; Break
IT WAS REPORTED THAT THE ITEM WAS BROKEN DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9459781 ↗MalfunctionApr 25, 2018Break; Break
IT WAS REPORTED THAT THE ATTUNE 3-5 DRILL STOPPER PIECES BROKE IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7459249 ↗
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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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