ATTUNE 2504-40-551Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295439875), received between Sep 22, 2019 and Apr 10, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BOSS REAMER WOULD NOT PASS THROUGH THE REAMER GUIDE AS INTENDED. AFTER VISUAL INSPECTION IT WAS FOUND TO HAVE BURS ON THE REAMER SHAFT KEEPING IT FROM ADVANCING. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19081463 ↗
• MalfunctionMar 14, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE BOSS REAMER IS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541726 ↗
• MalfunctionMar 15, 2022Material Integrity Problem; Material Integrity Problem

  TECHNICIAN REPORTS THAT DURING THE INSPECTION THERE WAS A DEFECTIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771471 ↗
• MalfunctionJan 10, 2022Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUTTING FLUTES ARE DAMAGED CREATING JAGGED EDGES. WILL NOT FIT SMOOTHLY THROUGH REVISION REAMER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204507 ↗
• MalfunctionNov 12, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING REAMING THE REAMER CAME IN CONTACT WITH PREVIOUS HARDWARE IN PATIENT AND GAUGED IT HEAVILY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803708 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS FOUND THAT D 250440551 FLUTES WERE WORN AND WOULD NOT FIT THROUGH THE REAMING TOWER/BARREL WHILE DEVICE WAS BEING CONSIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802518 ↗
• MalfunctionSep 22, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOSS REAMER WOULD NOT FIT DOWN BUSHING ADAPTERS OF THE CUT THROUGH TRIALS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9102259 ↗