ACTIS 2011-01-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295495666), received between Feb 5, 2021 and May 28, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE REAMER WAS BROKE AND A PORTION WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316075 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT THE ACTIS FLEX REAMER BROKE DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598368 ↗
• MalfunctionMar 11, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED, PROVIDING AN ANSWER FROM THE FOLLOWING QUESTION: 1. DID IT BROKE INTO TWO OR MORE PIECES, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? BROKE IN 2 PIECES. AND PARTS HAVE BEEN SHIPPED BACK ALREADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571150 ↗
• MalfunctionFeb 26, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING HIP REPLACEMENT SURGERY, ACTIS REAMER TIP BROKE OFF AND WAS RETAINED IN THE FEMORAL CANAL. REAMER WAS BEING USED TO EXPAND THE INNER DIAMETER OF THE FEMUR TO ACCOMMODATE THE FEMORAL COMPONENT. THE REAMER BROKE AT THE JUNCTION OF THE REAMER LEAVING APPROXIMATELY 6CM PIECE WITHIN THE SHAFT OF THE FEMUR. IT WAS DETERMINED TO BE UNSAFE TO TRY AND REMOVE THE PIECE AND IN ORDER TO NOT COMPROMISE THE FEMUR IT WAS LEFT IN PLACE. SURGERY WAS COMPLETED AND IT WAS DETERMINED THAT THIS WOULD NOT REQUIRE ANY CHANGES IN POSTOPERATIVE CARE. PATIENT DISCHARGED IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24457751 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY THE SURGEON WAS USING ACTIS DISTAL REAMERS AS USUAL AND THE INSTRUMENT BROKE. IT WAS REPORTED THAT THE SURGEON MANAGED THE SITUATION AND COMPLETED THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332749 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT SZ. 0-1 ACTIS FLEX REAMER WAS BROKEN. THE EVENT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120253 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF REAMER BROKE OFF IN FEMUR BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922100 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THE ACTIS REAMER BROKE IN THE FEMORAL CANAL. THE REAMER HEAD WAS UNABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803304 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, AT THE MOMENT OF BEGINNING WORK ON THE FEMORAL CANAL, THE FIRST BURR WAS USED. WHILE INSIDE THE BONE AND BEGINNING THE INITIAL BURRING FOR THE STEM PLACEMENT, THE INSTRUMENT BROKE INTO TWO PIECES UPON REMOVAL, LEAVING THE DISTAL PART OF THIS NEW INSTRUMENT INSIDE THE INTRAMEDULLARY CANAL. TO REMOVE THE METAL FRAGMENT THAT WAS RETAINED IN THE INTRAMEDULLARY CANAL, IT WAS NECESSARY TO ENTER THROUGH THE KNEE AND PUSH IT FROM DISTAL TO PROXIMAL, PUSHING IT WITH A GUIDE AND A HAMMER, AND USING BLOWS TO MANAGE TO ADVANCE THE BROKEN PIECE. THERE WAS A NINETY (90) MINUTE SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827474 ↗
• MalfunctionJun 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455091 ↗
• InjurySep 28, 2023Break; Break

  IT WAS REPORTED THAT THE REAMER HEAD SNAPPED OFF INTO FEMUR DURING REAMING. A WINDOW WAS MADE IN FEMUR TO REMOVE. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT 40-60 MINUTES.

  Patient problems: Limb Fracture; Unspecified Tissue Injury

  MAUDE report 17835458 ↗
• 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 17350963 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT UPON REAMING FEMORAL CANAL THE ACTIS REAMER FRACTURED AT THE BASE OF THE CUTTING AREA. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299495 ↗
• InjuryMay 1, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON WAS UTILIZING THE ACTIS SEMI-RIGID REAMERS DURING PRIMARY HIP REPLACEMENT (ANTERIOR) AND REAMER BROKE OFF ALONG STEM INSIDE FEMORAL CANAL. SURGEON HAD TO PERFORM WINDOW OSTEOTOMY IN A EFFORT TO REMOVE REAMER TIP. HAD TO CONVERT TO A EMPHASYS STEM IN ORDER TO BIPASS DEFECT IN FEMUR. THERE WAS A TWO HOURS OF SURGICAL DELAY.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 16843291 ↗
• MalfunctionMay 26, 2022Naturally Worn; Naturally Worn

  REAMER WAS STRIPPED WHERE IT WAS ATTACHED TO THE ADAPTER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516542 ↗
• MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE CASE THE ACTIS REAMER GOT STUCK IN THE FEMORAL CANAL. IT HAD TO BE CUT AND TREPHINED OVER TO GET IT OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727148 ↗
• 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 11289536 ↗

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