ACTIS 2010-01-030Recalls & reported problems
Depuy (Ireland) · ACTIS BROACH SIZE 3 · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Actis broach is a surgical instrument used in joint replacement surgery. Many of the 125 reports describe broaches that broke, did not fit with other instruments, or could not be removed, and most say the patient was not affected. The reports include no deaths and 1 injury. 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
- 131
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10603295393658), received between May 1, 2018 and Sep 1, 2026 — classified as 1 injury, 130 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (58 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility58
- Break42
- Scratched Material18
- Failure to Cut15
- Material Deformation15
- Difficult to Advance9
- Material Twisted/Bent6
- Fitting Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- No Consequences Or Impact To Patient28
- Insufficient Information10
- Not Applicable8
- No Code Available2
Recent adverse event reports
The 25 most recent of 131 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 50544345 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355877 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355846 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355763 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355745 ↗MalfunctionAug 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251331 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732765 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731517 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THE OLD STYLE ACTIS BROACHES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730435 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607075 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607036 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607031 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606929 ↗MalfunctionMar 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE BROACH WAS UNABLE TO EXTRACT WITH BROKEN TRUNION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606878 ↗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 24071130 ↗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 24071124 ↗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 24071120 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE TEETH WERE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850053 ↗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 23283457 ↗MalfunctionOct 10, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THERE ARE SEVERE STRESS RINGS ON ACTIS BROACHES WHERE THEY ATTACH TO BROACH HANDLE. SURGEON FREQUENTLY BREAKS THEM AND WHEN THEY BREAK IT IS EXTREMELY HARD TO REMOVE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23272691 ↗MalfunctionAug 15, 2025Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE SIZE 3 ACTIS BROACH BROKE IN THE IMPACTION PART OF CASE. IT BROKE WHERE IT CONNECTS TO DUAL OFFSET HANDLE. CANNOT READ LOT NUMBER, THE CATALOG NUMBER OR SERIAL NUMBER AS ETCHING IS FAINT AND WORN. NO HARM WAS DONE TO PATIENT. NO DELAY AS REP HAD BACKUP TRAYS. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815327 ↗MalfunctionAug 1, 2025Improper or Incorrect Procedure or Method; Scratched Material; Illegible Information; Improper or Incorrect Procedure or Method; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SURGEON WAS BROACHING FOR A TOTAL HIP AND THE NURSE ACCIDENTALLY HANDED UP THE INCORRECT BROACHES AS TWO OF THEM HAD NUMBERS ON THEM THAT WERE SCRATCHED OFF AND WORN AWAY DUE TO WEAR AND TEAR OVER TIME. SURGEON WAS UPSET AS HE BROACHES A LARGER SIZE THAN HE THOUGHT AND COULD HAVE FRACTURED THE FEMUR IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SHORT DELAY IN PROCEDURE. NO PATIENT ISSUES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686278 ↗MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE, A SIZE 3 BROACH BECAME JAMMED INTO THE BROACH HANDLE AND KINCISE ADAPTER. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176197 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE ACTIS HIP BROACHES POSTS SHEARED OFF AND DO NOT HAVE THE T-SLOT FOR EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115184 ↗MalfunctionMay 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A THA SURGERY. DURING THE SURGERY, THE BROACH WAS NOT ABLE TO BE ATTACHED TO THE BROACH HANDLE. THE BROACH WAS NOT ABLE TO BE ATTACHED TO ANY OTHER BROACH HANDLE, SO IT WAS PRESUMED THAT THIS WAS MOST LIKELY DUE TO A DEFECT IN THE BROACH ITSELF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080989 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page