QUICKSET 2440-00-567Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10603295124146), received between Sep 20, 2017 and Aug 4, 2025 — classified as 120 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (63 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 120 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 HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED FOR CAPTURED ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707890 ↗
• MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED FOR CAPTURED ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707349 ↗
• MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED FOR CAPTURED ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706950 ↗
• MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED FOR CAPTURED ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706691 ↗
• MalfunctionAug 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED FOR CAPTURED ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706044 ↗
• MalfunctionAug 1, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689982 ↗
• MalfunctionAug 1, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689980 ↗
• MalfunctionAug 1, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689978 ↗
• MalfunctionJul 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631778 ↗
• MalfunctionJul 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAVE BECOME DULL OVER TIME AND NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631666 ↗
• MalfunctionJul 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENTS HAD AN UNKNOWN ALLEGATION AND NEED REPLACED WITH CROSS BACKS. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS FOUND THAT THERE WAS BLUNTING OF CUTTING EDGES. ADDITIONALLY, CORROSION PATTERNS WERE FOUND BOTH OUTSIDE AND INSIDE OF THE CUTTING SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414456 ↗
• MalfunctionApr 21, 2025Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE RUSTY PINNACLE REAMERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874862 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517943 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517812 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517702 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517646 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517632 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517413 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517384 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAD BECOME DULL OVER TIME AND NEED TO BE REPLACED. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516786 ↗
• MalfunctionFeb 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS ARE DULL. THE EVENT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461842 ↗
• MalfunctionOct 10, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO SURGICAL DELAY FOR ANY OF THESE REPORTED DEVICES, HOWEVER, TIME IS REQUIRED TO ORDER LOANER SETS WHILE WAITING FOR MISSING ITEMS TO BE RESTOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422117 ↗
• MalfunctionJul 24, 2024Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMERS WERE DULL. HANDLES DIDN¿T FIT.

  Patient problems: Insufficient Information

  MAUDE report 19816493 ↗
• MalfunctionJul 22, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENT WAS DULL.

  Patient problems: Insufficient Information

  MAUDE report 19798578 ↗
• MalfunctionJul 22, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PRODUCTS WERE DULL.

  Patient problems: Insufficient Information

  MAUDE report 19797889 ↗