ATTUNE 2545-00-048Recalls & reported problems
Depuy (Ireland) · ATTUNE RASP · 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 10603295130550), received between Jul 2, 2019 and Jul 25, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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
- Failure to Cut13
- Break8
- Naturally Worn4
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE DEVICE LOST IT'S SHARPNESS AND DOESN'T RASP EFFECTIVELY. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610359 ↗MalfunctionJul 25, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE DEVICE LOST IT'S SHARPNESS AND DOESN'T RASP EFFECTIVELY. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610334 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTORS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475128 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTORS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475118 ↗MalfunctionJan 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE ATTUNE RASP IS SOFT ON ONE SIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218845 ↗MalfunctionJul 3, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE BASE PINS WERE DULL, FEM IMPACTOR BROKE, 3-5 AND 6-8 RINGS WERE OLD AND PAINT WORN OFF, THE RASPS WERE OLD AND DULL, ANGEL WINGS WERE BENT.
Patient problems: Insufficient Information
MAUDE report 19665458 ↗MalfunctionJul 3, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE BASE PINS WERE DULL, FEM IMPACTOR BROKE, 3-5 AND 6-8 RINGS WERE OLD AND PAINT WORN OFF, THE RASPS WERE OLD AND DULL, ANGEL WINGS WERE BENT.
Patient problems: Insufficient Information
MAUDE report 19665450 ↗MalfunctionJul 3, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THE BASE PINS WERE DULL, FEM IMPACTOR BROKE, 3-5 AND 6-8 RINGS WERE OLD AND PAINT WORN OFF, THE RASPS WERE OLD AND DULL, ANGEL WINGS WERE BENT.
Patient problems: Insufficient Information
MAUDE report 19665413 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE RASP IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 18901820 ↗MalfunctionJan 9, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE SURGEON COMPLAINED OF DULL RASP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475638 ↗MalfunctionJan 3, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THERE WERE DULL STEP DRILL AND DULL RASP. THERE WAS NO DELAY OR CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18440807 ↗MalfunctionDec 28, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PATELLA FEMORAL LUG DRILL WAS DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18408958 ↗MalfunctionNov 16, 2023Failure to Cut; Failure to Cut
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? -NO PATIENT CONSEQUENCES. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? -YES. 2 MINUTE DELAY. C. PLEASE CONFIRM IF THERE WAS ANY ALLEGED DEVICE DEFICIENCY REPORTED FOR THE 254501707 (ATTUNE CR TRIALS SZ 3-8)? -PAINT CHIPPING. UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18156722 ↗MalfunctionDec 12, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT RASP IS DULL, ANGEL WING BENT, AND PIN DRIVER STICKS TO HUDSON. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15960482 ↗MalfunctionOct 19, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635165 ↗MalfunctionOct 19, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15634811 ↗MalfunctionApr 29, 2022Break; Break
INSTRUMENTS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250290 ↗MalfunctionApr 11, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT THIS ITEM ISN¿T WORKING AS IT SHOULD DUE TO THE WEAR. THE INSTRUMENT IS NOT SHARP. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14073138 ↗MalfunctionDec 7, 2021Break; Break
INSTRUMENTS BROKE DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953394 ↗MalfunctionDec 7, 2021Break; Break
INSTRUMENTS BROKE DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12953393 ↗MalfunctionJan 22, 2021Break; Break
RASP, TIBIAL & FEMORAL IMPACTOR, 49 MM GRATER BROKEN. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11213152 ↗MalfunctionJul 2, 2019Break; Break
IT WAS REPORTED THAT WHEN AUDITING CHARLESTON'S ATTUNE TRAYS, THE SALES REP CAME ACROSS BROKEN INSTRUMENTS THAT MAY HAVE BEEN THROWN AWAY BUT WAS ABLE TO GRAB BROKEN PITCH FORK. THIS DID NOT IMPACT THE CASES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8753257 ↗
Other RASP devices
- P.F.C. 85-3927Depuy (Ireland) · RASP11 reports
- DePuy Sythes 10-306-000Symmetry Medical Inc. · Rasp11 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005613Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005610Zimmer, Inc. · Rasp3 reports
- EXACT REVERSE FP FULL TOOTH RASP SSI005614Zimmer, Inc. · Rasp3 reports
- ALIF 389.156Synthes GmbH · RASP3 reports
- ALIF 03.808.101Synthes GmbH · RASP2 reports
- Calix Spinal Implant System C003-0027Xtant Medical Holdings, Inc. · RASP1 report
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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