QUICKSET 2440-00-538Recalls & reported problems
Depuy (Ireland) · QUICKSET GRATER HEAD 38mm · 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 attachment. Many reports describe graters that became dull or failed to cut, and some mention corrosion, usually noticed outside of surgery. The 157 reports include no deaths and no injuries. No recalls name this device, and reports fell from 13 in the prior 12 months to none in the latest 12 months.
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
- 157
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10603295123859), received between Sep 20, 2017 and Jul 28, 2025 — classified as 157 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (85 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 Cut85
- Corroded29
- Dull, Blunt18
- No Apparent Adverse Event16
- Naturally Worn8
- Crack4
- Material Twisted/Bent4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions119
- No Consequences Or Impact To Patient31
- Insufficient Information8
- No Information2
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS ARE DULL AND NEED REPLACED (WITH CROSSBACK GRATERS). IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631473 ↗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 22587789 ↗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 22587609 ↗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 22413996 ↗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 21855131 ↗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 21677710 ↗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 21677254 ↗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 21545785 ↗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 21545602 ↗MalfunctionMar 6, 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 21537482 ↗MalfunctionMar 6, 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 21537031 ↗MalfunctionMar 5, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEEDS TO BE REPLACED. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525060 ↗MalfunctionMar 5, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEEDS TO BE REPLACED. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21524980 ↗MalfunctionSep 6, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE REAMERS DULL - NEED REPLACEMENTS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20156540 ↗MalfunctionSep 4, 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 20134374 ↗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 20125980 ↗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 20125975 ↗MalfunctionJul 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PRODUCTS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19781532 ↗MalfunctionJul 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19781498 ↗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 19775514 ↗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 19702935 ↗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 19499991 ↗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 19499976 ↗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 19499956 ↗MalfunctionMay 10, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT REAMERS WERE DULL. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19286723 ↗
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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