QUICKSET 2440-00-536Recalls & reported problems
Depuy (Ireland) · QUICKSET GRATER HEAD 36mm · 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 describe corrosion. The 157 reports include no deaths and no injuries. No recalls name this device, and reports fell from 23 in the prior 12 months to 1 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 10603295123835), received between Aug 9, 2017 and Nov 18, 2025 — classified as 157 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (74 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 Cut74
- No Apparent Adverse Event26
- Corroded25
- Dull, Blunt21
- Device-Device Incompatibility5
- Naturally Worn5
- Adverse Event Without Identified Device or Use Problem4
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- No Consequences Or Impact To Patient34
- Insufficient Information8
- No Information3
- No Code Available2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE SURGEON REQUESTED GRATER BE REPLACED DUE TO IT NOT BEING SHARP ENOUGH TO REAM BONE. THERE WAS NOTHING LEFT IN PATIENT AND NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582666 ↗MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME . (B)(4) IS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22700251 ↗MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME.(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699635 ↗MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699387 ↗MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME. (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699304 ↗MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME. (B)(4) IS RELATED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699164 ↗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 DIDNT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630669 ↗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 DIDNT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630380 ↗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) AND (B)(4) ARE RELATED TO EACH OTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586527 ↗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 22586398 ↗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 22413976 ↗MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATER SETS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. EVENT DIDN'T HAPPEN IN SURGERY. (B)(4). FOR ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385860 ↗MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATER SETS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. EVENT DIDN'T HAPPEN IN SURGERY. (B)(4). FOR ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385640 ↗MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATER SETS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. EVENT DIDN'T HAPPEN IN SURGERY. (B)(4) IS RELATED TO: (B)(4). FOR ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385330 ↗MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE GRATER SETS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. EVENT DIDN'T HAPPEN IN SURGERY. (B)(4). FOR ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385204 ↗MalfunctionMay 14, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT SEVERAL INSTRUMENTS WERE DAMAGED. THE MEDIUM SIZE DRILL BROKE INTO TWO PIECES DURING USE. THE ACETABULAR CUTTERS ARE NOT SHARP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22017320 ↗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 21537251 ↗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 21537120 ↗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 21537096 ↗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 21536858 ↗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 21525498 ↗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 21525114 ↗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 21525092 ↗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 21524826 ↗MalfunctionSep 3, 2024Corroded; Corroded
IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL AND NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125986 ↗
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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