QUICKSET 2440-00-540Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 10603295123873), received between Sep 20, 2017 and Jul 24, 2025 — classified as 189 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (121 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 189 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) AND (B)(4) ARE RELATED TO EACH OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588185 ↗
• 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 22588153 ↗
• 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 22509348 ↗
• 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 22509345 ↗
• 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 22413998 ↗
• 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).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170988 ↗
• 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 22170876 ↗
• 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 22170685 ↗
• MalfunctionJun 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS WERE DULL. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144642 ↗
• 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 21678023 ↗
• 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 21677985 ↗
• MalfunctionMar 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE PRODUCT WAS RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS REVEALED ROUNDING OF THE CUTTING EDGES. ADDITIONALLY, CORROSION PATTERNS WERE FOUND BOTH INSIDE AND OUTSIDE OF THE CUTTING SURFACE. IT IS NOT UNREASONABLE THAT THE CONDITION IDENTIFIED IN VISUAL ANALYSIS WOULD CONTRIBUTE TO A DULL CONDITION. THEREFORE WE ARE ABLE TO CONFIRM DULLNESS WITH DAMAGE OBSERVED, AS THIS KIND OF EVIDENCE INDICATES REPEATED USE OF THE DEVICE. WHERE CORROSION/OXIDATION WAS IDENTIFIED AROUND THE CUTTING SURFACE OF THE DEVICE, ALONGSIDE DAMAGE CONSISTENT WITH NORMAL WEAR, THIS SUGGESTS THAT THE PASSIVE LAYER OF THE METAL HAS BEEN WORN DOWN FROM REPEATED USE (DUE TO NORMAL USE DAMAGE) ALLOWING FOR THE METALLIC SURFACE UNDERNEATH TO BECOME SUSCEPTIBLE TO CORROSION/OXIDATION. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE IN CLINICAL PRACTICE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677960 ↗
• 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 21677381 ↗
• 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 21546163 ↗
• 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 21546057 ↗
• 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 21545709 ↗
• 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 21545571 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. THE BREAKAGE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915261 ↗
• MalfunctionDec 12, 2024Corroded; Crack; Corroded; Crack

  IT WAS REPORTED THAT A 40 MM GRATER WAS CRACKED AND RUSTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915159 ↗
• 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 20559053 ↗
• MalfunctionSep 24, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE REAMER IS RUSTY AND WAS FOUND BY STERILIZATION SERVICES SO THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295717 ↗
• 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 20134394 ↗
• 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 20125971 ↗
• MalfunctionJul 19, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PRODUCTS WERE DULL.

  Patient problems: Insufficient Information

  MAUDE report 19781610 ↗
• MalfunctionJul 19, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL.

  Patient problems: Insufficient Information

  MAUDE report 19781597 ↗