ACTIS 2010-01-040Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 4 · Class 1
Quick summary
This DePuy ACTIS hip broach has 166 reports, with no deaths and 4 injuries. Many reports describe broaches breaking, including parts breaking off inside the bone canal, and some describe parts that did not fit together or failed to cut. Some reports say a broken broach caused a delay in surgery. No recalls name this device, and reports fell from 24 in the prior 12 months to 13 in the latest 12 months.
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
- 172
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 10603295393665), received between Dec 13, 2017 and Sep 22, 2026 — classified as 4 injuries, 168 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (63 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 Incompatibility63
- Break62
- Scratched Material27
- Failure to Cut16
- Material Deformation14
- Difficult to Advance12
- Material Twisted/Bent10
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions108
- No Consequences Or Impact To Patient34
- Insufficient Information18
- No Code Available8
- Not Applicable3
- Bone Fracture(s)1
- Nerve Damage1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849534 ↗MalfunctionSep 1, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544485 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356345 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356326 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356253 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356239 ↗MalfunctionMay 4, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY WHILE TRYING TO REMOVE THE BROACH FROM THE FEMORAL CANAL, THE MALE END WHERE THE BROACH HANDLE ATTACHES BROKE OFF IN THE BROACH ATTACHMENT FOR THE K2. THE USER HAD TO USE THE BROACH EXTRACTOR FOR A NEW STYLE BROACH TO GET IT OUT OF THE CANAL. THIS CAUSED A DELAY IN THE SURGERY. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072224 ↗MalfunctionApr 28, 2026Material Deformation; Scratched Material
IT WAS REPORTED DURING MDRD INSPECTION, SEVERAL ACTIS BROACHES WERE FOUND TO BE DAMAGED. THE BROACHES HAD LARGE DENTS AND CURLING OF THE METAL ON THE COMPACTION TEETH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014600 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735008 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24734091 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732388 ↗MalfunctionMar 12, 2026Break
IT WAS REPORTED THAT BROACHES ARE BROKEN INTO TWO PIECES. NO ADDITIONAL FRAGMENTS. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583889 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED THAT THERE WAS BROKEN BROACHES/T HANDLE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305549 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071131 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071128 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SIZE 6 BROACH TRUNION SNAPPED DURING EXTRACTION. IT BROKE DURING REMOVAL. NO TIME ADDED. ALL PARTS WERE RETRIEVED. SWAPPED ALL BROACHES FOR SLOTTED BROACHES FOR EASE OF EXTRACTION PER SURGEON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071117 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT BROACH JUNCTION SNAPPED FOR BOTH SIZES 4 AND 5 WHILE IMPACTING WITH KINCISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019231 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT'S ATTACHMENT POINT WHERE THE HANDLE CONNECTS SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837749 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THAT SIZE 4 BROACH TRUNNION SNAPPED OFF. USING K2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680680 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEEDED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO THE BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK, IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23283460 ↗MalfunctionOct 15, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS BROACHES NEEDED TO BE REPLACED. THERE WERE SEVERE STRESS RINGS ON THEM WHERE THEY ATTACH TO THE BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM. WHEN THEY BREAK, IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23283205 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT THE ACTIS 4 BROACH BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964232 ↗MalfunctionAug 21, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE BROACHING THE FEMUR, THE POST ON THE TOP OF THE ACTIS BROACH BROKE OFF. THIS PREVENTS THE BROACH HANDLE FROM LOCKING ONTO THE BROACH. THE BROACH WAS BEING IMPACTED AND WAS NEARLY FLUSH WITH THE NECK RESECTION, MAKING IT DIFFICULT TO ACCESS AND EXTRACT. THE SURGEON SPENT SEVERAL HOURS TRYING TO RETRIEVE THE BROKEN BROACH. THIS WAS A GEN 2 BROACH, SO THERE WAS NOT AN EXTRACTION SLOT ON THE TOP OF THE BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859055 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT METAL SHAVINGS WERE COMING FROM THE ACTIS BROACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839392 ↗MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRUNNION ON BROACH IS WORN AND NECK TRIALS WON¿T FIT ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708596 ↗
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 2010-01-070Depuy (Ireland) · BROACH162 reports
- CORAIL 952210500FDepuy (Ireland) · BROACH157 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.