ACTIS 2011-01-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295495673), received between Aug 26, 2019 and Jun 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150862); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ACTIS REAMER WAS BENT AND NO LONGER STRAIGHT AND WAS UNUSABLE. THE DEVICE WAS DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375047 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT AT THE PATIENT'S LEFT FEMUR, THE ACTIS 2/3 DISTAL REAMER BROKE AT THE JUNCTION OF THE SHAFT AND THE HUDSON END WHILE DISTALLY REAMING. DOCTOR THEN USED A JACOBS CHUCK TO GRAB THE REAMER AND REMOVED IT FROM THE PATIENT'S FEMUR. ALL PIECES WERE RECOVERED AND ACCOUNTED FOR. THERE WAS A MINUTE DELAY AS A RESULT OF THE REAMER BREAKING. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113169 ↗
• MalfunctionJul 19, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT REAMERS WERE DULL. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350983 ↗
• MalfunctionFeb 5, 2021Break; Failure to Cut; Break; Failure to Cut

  SURGEON NOTICED THE PROBLEM ON ACTIS REAMER STABILIT AND SAW THE RISK OF THE BROKEN REAMER DURING SURGERY. THICKNESS OF THE REAMER BODY SEAMS ARE TOO WEAK EVEN THOUGH NO EVENT HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11289431 ↗
• MalfunctionDec 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE REMEAR BENT DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11049759 ↗
• MalfunctionAug 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ATTUNE REAMER 2/3 WAS BENT WHILE REAMING THE IM CANAL DURING A THA. THE DR. WAS REAMING WHEN HE HIT HARD BONE AND THE REAMER BENT. THERE WAS NO INDICATION THE PRODUCT WAS DEFICIENT AND NO PARTS OF THE REAMER WAS BROKEN OFF OF THE DEVICE. THIS PART WAS BEING SENT BACK TO DEPUY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930056 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150862. One submission often covers many models, so check the product and lot details in each record.

• Z-0650-2017 · Oct 25, 2016 · Terminated
  ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with labe