QUICKSET 2440-00-539Recalls & reported problems
Depuy (Ireland) · QUICKSET GRATER HEAD 39mm · Class 1
All models of QUICKSET (66)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy QuickSet grater head is a surgical reamer head used during orthopedic surgery. Of its 171 reports, many describe the grater failing to cut, along with corrosion and dulling over time. The reports mention no deaths and no injuries, and no recalls name this device. Reports stopped over the past 12 months, with none compared with 15 in the year before.
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
- 171
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 10603295123866), received between Sep 1, 2017 and Jul 24, 2025 — classified as 171 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (99 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 Cut99
- Corroded32
- No Apparent Adverse Event17
- Dull, Blunt10
- Naturally Worn9
- Break6
- Material Twisted/Bent6
- Material Deformation4
Patient problems
- No Clinical Signs, Symptoms or Conditions135
- No Consequences Or Impact To Patient27
- Insufficient Information9
- No Information3
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THIS EVENT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587875 ↗MalfunctionJul 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THIS EVENT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587867 ↗MalfunctionJul 15, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE GRATERS ARE VERY OLD AND NOT CUTTING AS WELL AS THE NEW ONES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509335 ↗MalfunctionJul 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT ITEMS NEED REPLACED WITH CROSS BACKS. A PRODUCT HAS BEEN REPORTED BUT THE REASON FOR REPORTING IS UNKNOWN. THIS EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS FOUND THAT THE CUTTING EDGES OF THE DEVICE ARE BLUNTING/ROUNDING. ADDITIONALLY SIGNS OF CORROSION WERE OBSERVED AROUND THE CUTTING SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413993 ↗MalfunctionJun 9, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED INSTRUMENTS WERE REPORTED FOR UNKNOWN ISSUE. IT DID NOT HAPPEN IN SURGERY. (B)(4) IS LINKED TO (B)(4) AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170451 ↗MalfunctionJun 9, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED INSTRUMENTS WERE REPORTED FOR UNKNOWN ISSUE. IT DID NOT HAPPEN IN SURGERY. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170227 ↗MalfunctionApr 17, 2025Break; Crack; Material Deformation; Break; Crack; Material Deformation
IT WAS REPORTED THAT THE TECH NOTICED ALL 3 GRATERS HAD THE GRATER CUT OUT BENT INWARD AND WERE DULL, THE OTHER LOOKED TO HAVE A SMALL CRACK ON THE CROSS SECTION ALONG THE BACKSIDE THAT CONNECTS TO HANDLE. THE GRATERS WERE PULLED FROM THAT TRAY. NO ISSUES WITH DELAYS OR ISSUES WITH THE GRATERS USED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855129 ↗MalfunctionMar 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER REPEATED USE AND TIME. THE EVENT DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677867 ↗MalfunctionMar 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER REPEATED USE AND TIME. THE EVENT DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677840 ↗MalfunctionMar 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER REPEATED USE AND TIME. THE EVENT DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677774 ↗MalfunctionMar 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER REPEATED USE AND TIME. THE EVENT DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677311 ↗MalfunctionMar 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME WITH REPEATED USE. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546043 ↗MalfunctionMar 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME WITH REPEATED USE. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545946 ↗MalfunctionMar 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME WITH REPEATED USE. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545907 ↗MalfunctionMar 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME WITH REPEATED USE. THE ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545647 ↗MalfunctionOct 29, 2024Corroded; Failure to Cut; Material Deformation; Naturally Worn; Corroded; Failure to Cut; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL AND NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559285 ↗MalfunctionSep 3, 2024Corroded; Corroded
IT WAS REPORTED THAT THE GRATERS ARE RUSTY SO SPD WILL NOT STERILIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127310 ↗MalfunctionSep 3, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL AND NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125978 ↗MalfunctionJul 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PRODUCTS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19781539 ↗MalfunctionJul 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19781510 ↗MalfunctionJul 18, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE REAMERS WERE DULL. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19775400 ↗MalfunctionJul 9, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
STAFF HAVE INDICATED THAT THE GRADERS REQUIRE A REPLACEMENT DUE TO WEAR AND TEAR AND BEING DULL OVERTIME. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19702776 ↗MalfunctionJun 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE CROSSBACK GRATER WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE SURFACE OF THE QUICKSET ACE GRATER HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19511145 ↗MalfunctionJun 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE CROSSBACK GRATER WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE SURFACE OF THE QUICKSET ACE GRATER HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19511133 ↗MalfunctionJun 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE CROSSBACK GRATER WAS REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE DEVICE REVEALED THAT THE CUTTING EDGED PRESENTS SIGNS OF WEAR CONSISTENT WITH REPEATED USE AND SERVICING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19499977 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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