ACTIS 2011-01-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295495680), received between Nov 30, 2018 and Feb 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS REAMER WOULD NOT LOCK INTO THE HUDSON ADAPTER. SURGICAL DELAY WAS APPROXIMATELY FIVE MINUTES FOR OBTAINING ANOTHER TRAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426032 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT THE REAMER HANDLE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894996 ↗
• 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 17350994 ↗
• MalfunctionJul 14, 2023Break; Break

  IT WAS REPORTED THAT THE 4/5 ACTIS DISTAL REAMER BROKE WHILE REAMING. IT BROKE CLEANLY WITH NO DEBRIS OR PIECES BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17327341 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED AS "WHILE REAMING THE FEMORAL CANAL, THE ACTIS 4/5 REAMER SHAFT SHEARED AND BROKE OFF, LEAVING THE REAMER TIP BEHIND. REAMER TIP WAS RETRIEVED AND REMOVED FROM FEMUR." SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12211712 ↗
• 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 11289490 ↗
• MalfunctionNov 30, 2018Break; Break

  ADAPTER BROKE.

  Patient problems: Not Applicable

  MAUDE report 8121389 ↗

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