QUICKSET 2440-00-561Recalls & reported problems

Summary

The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 10603295124085), received between Sep 21, 2017 and Jul 15, 2025 — classified as 418 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (305 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 418 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508102 ↗
• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508097 ↗
• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508096 ↗
• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508093 ↗
• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508090 ↗
• MalfunctionJul 15, 2025Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT OLD PINNACLE GRATERS NEEDED TO BE REPLACED. DOCTORS COMPLAINED THAT THEY WERE VERY DULL AND STERILE PROCESSING COMPLAINED OF RUST AND WARPING. THESE ARE OVER 10 YEARS OLD. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508089 ↗
• MalfunctionJul 8, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS HAD BECOME DULL AND NEED TO BE REPLACED. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437677 ↗
• MalfunctionJun 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184049 ↗
• MalfunctionJun 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS WERE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183162 ↗
• MalfunctionJun 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. UPON MANUFACTURERS INVESTIGATION IT WAS NOTED THAT THE INSTRUMENT HAS CORROSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131278 ↗
• 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 21874855 ↗
• 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 21678321 ↗
• 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 21678212 ↗
• 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 21517404 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514504 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514381 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514218 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE GRATERS HAVE BECOME DULL OVER TIME AND NEED REPLACEMENT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513867 ↗
• MalfunctionFeb 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GRATERS WERE DULL. THE ISSUE DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453915 ↗
• MalfunctionJan 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE HAS ROUNDING OF CUTTING EDGES AND CORROSION PATTERNS ON BOTH INSIDE AND OUTSIDE OF THE CUTTING SURFACE.

  Patient problems: Insufficient Information

  MAUDE report 21152343 ↗
• MalfunctionJan 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DEVICE HAS ROUNDING OF CUTTING EDGES AND CORROSION PATTERNS ON BOTH INSIDE AND OUTSIDE OF THE CUTTING SURFACE.

  Patient problems: Insufficient Information

  MAUDE report 21152301 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE GRATER WAS BENT AND WOULDN¿T ATTACH TO THE REAMER HANDLE. THIS WAS DISCOVERED PRIOR TO A TOTAL HIP REPLACEMENT ON (B)(6) 2024. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21081508 ↗
• MalfunctionNov 13, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE DULL ACETABULAR GRATERS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677729 ↗
• MalfunctionNov 13, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE DULL ACETABULAR GRATERS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677649 ↗
• MalfunctionNov 12, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE DULL ACETABULAR GRATERS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667479 ↗