QUICKSET 2440-00-537Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 10603295123842), received between Sep 20, 2017 and Aug 4, 2025 — classified as 171 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (88 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 171 reports, in the reporter's own words as published by the FDA.

• 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 22702786 ↗
• 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 22702272 ↗
• 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 22702025 ↗
• 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 22701242 ↗
• 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 22700680 ↗
• 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 22638108 ↗
• 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 22631271 ↗
• 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 22630899 ↗
• 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 22630764 ↗
• 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 22586659 ↗
• 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 22586550 ↗
• 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 22413988 ↗
• 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 22386416 ↗
• 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. IS RELATED TO: (B)(4) FOR ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386146 ↗
• 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 21537449 ↗
• 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 21537394 ↗
• 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 21537155 ↗
• 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 21536896 ↗
• 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 21525367 ↗
• 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 21525332 ↗
• 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 21525282 ↗
• 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 21524925 ↗
• MalfunctionFeb 12, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: 1. UNKNOWN AS TO WHERE THE EVENT OCCURRED, ITEM WAS FOUND TO BE BROKEN IN THE LOCAL DISTRIBUTOR'S OFFICE. 2. IT DID NOT, ITEM IS CRACKED BUT STILL IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366639 ↗
• 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 20127223 ↗
• 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 20125974 ↗