ACTIS 2010-01-002Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH STARTER · Class 1
Quick summary
This DePuy ACTIS starter broach is a surgical instrument used to shape the bone cavity in hip replacement surgery. The 46 reports mostly describe the instrument breaking, bending, scratching or failing to cut properly, and pieces not fitting or locking onto the broach handle. In one report, a broken piece stayed in the patient until it was removed. There are 46 malfunction reports, with no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295393610), received between May 3, 2018 and Sep 1, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (23 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility23
- Failure to Cut9
- Break6
- Material Deformation5
- Material Twisted/Bent4
- Scratched Material4
- Appropriate Device Problem Term/Code Not Available2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Consequences Or Impact To Patient12
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543839 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE PLANAR SHAFT AND STARTER BROACH WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164572 ↗MalfunctionMay 5, 2026Material Deformation
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE STARTER BROACH WAS BENT, ACTIVITY LEVEL - YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086871 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT WHILE USING THE STARTER BROACH AS A RESECTION GUIDE, THE SURGEON CUT OF THE NECK/TRUNION OF THE BROACH. WHILE RUNNING TO GET ANOTHER SET FOR THE STARTER BROACH, THE CIRCULATING NURSE THREW THE BROACH IN THE SHARPS BIN AND WAS NOT RETRIEVABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753910 ↗MalfunctionFeb 17, 2026Break; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT PROXIMAL TIP OF BROACH WAS DAMAGED AND GETTING STUCK IN KINCISE BROACH ADAPTOR HANDLE. ACTIS STARTER BROACH. CODE AND LOT NUMBERS ARE WORN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363075 ↗MalfunctionJul 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ACTIS STARTER BROACH IS BENT AT THE TRUNION AND WILL NOT FIT ON A BROACH HANDLE. SURGERY TIME WAS NOT EXTENDED AND THE INSTRUMENT IS NOT BROKEN INTO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540324 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED THAT BROKEN INSTRUMENTS AT HOSPITAL WAS DISCOVERED. UNKNOWN IF SURGERY WAS DELAYED, FRAGMENTS GENERATED OF IF PROCEDURE WAS SUCCESSFULLY COMPLETED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22092278 ↗MalfunctionMay 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STARTER BROACH'S DID NOT LOCK ONTO BROACH HANDLE.
Patient problems: Insufficient Information
MAUDE report 19320719 ↗MalfunctionMay 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STARTER BROACH'S DID NOT LOCK ONTO BROACH HANDLE.
Patient problems: Insufficient Information
MAUDE report 19320709 ↗MalfunctionFeb 16, 2024Break; Break
IT WAS REPORTED THAT THE STARTER BROACH METAL TRUNION WAS BROKEN. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720381 ↗MalfunctionJan 24, 2024Device-Device Incompatibility; Device-Device Incompatibility
A. WAS THERE ANY SURGICAL DELAY ? -NO DELAY. B. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. -NO ADVERSE CONSEQUENCES, JUST SOMETHING DR. HART NOTICED. C. WAS THERE AN ALLEGATION WITH THE BROACH HANDLE, SINCE THE DER IS REPORTING ONLY THE BROACH? -IT WAS JUST THE 2 BROACHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570324 ↗MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH NECK WILL NOT ATTACH TO HANDLE. OTHER BROACHES TRIED AND ATTACH AS INTENDED. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? --> NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01931136 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->FIELD OPS BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18434749 ↗MalfunctionNov 28, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT STARTER BROACH WILL NOT ATTACH TO BROACH HANDLES. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18221086 ↗MalfunctionSep 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STARTER BROACH WILL NO LONGER ATTACH TO BROACH HANDLES. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844511 ↗MalfunctionSep 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WERE BLACK STAINS ON THE STARTER . THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17777535 ↗MalfunctionAug 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ACTIS STARTER BROACH WILL NOT ENGAGE THE BROACH HANDLE. NO HARM TO THE PATIENT, NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17595537 ↗MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE BROACHES ARE ¿STICKING¿ IN THE HANDLES AND A FEW SIZE 5 HAVE ACTUALLY BROKEN IN SPD WHEN TRYING TO SEPARATE FROM THE HANDLES. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434356 ↗MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE BROACHES ARE ¿STICKING¿ IN THE HANDLES AND A FEW SIZE 5 HAVE ACTUALLY BROKEN IN SPD WHEN TRYING TO SEPARATE FROM THE HANDLES. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434307 ↗MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE BROACHES ARE ¿STICKING¿ IN THE HANDLES AND A FEW SIZE 5 HAVE ACTUALLY BROKEN IN SPD WHEN TRYING TO SEPARATE FROM THE HANDLES. NO OTHER INFORMATION IS AVAILABLE. ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434305 ↗MalfunctionJul 14, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE STARTER BROACH MALE TRUNNION ADAPTER WAS SCORED AND MODULAR BOX OSTEOTOME WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17327449 ↗MalfunctionMay 26, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009721 ↗MalfunctionMar 9, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511833 ↗MalfunctionFeb 27, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACH ARE DULL. NEED TO REPLACE 5 CONSIGNMENT SETS, SIZES 0- 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16442356 ↗MalfunctionFeb 27, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE ACTIS BROACHES ARE DULL. NEED TO REPLACE 5 CONSIGNMENT SETS, SIZES 0- 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16442332 ↗MalfunctionNov 8, 2022Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE BROACH'S TRIAL NECK/BROACH HANDLE MALE ATTACHMENT BECAME DAMAGED. WILL NO LONGER EXCEPT TRAIL NECK/HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15751113 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.