ACTIS 2010-07-110Recalls & reported problems
Depuy (Ireland) · ACTIS STRAIGHT INSERTER SHAFT · Class 1
Quick summary
This DePuy Actis straight inserter shaft is a surgical instrument used to place the stem during hip replacement. The 47 reports mostly describe the shaft arriving bent or deformed so it will not engage with the handle or insert properly, along with some breakage and surface damage, and incompatibility with other instruments. No deaths or injuries are reported. There are no recalls naming 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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295393993), received between Jul 19, 2019 and Sep 17, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (30 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 Incompatibility30
- Material Deformation8
- Break6
- Scratched Material5
- Naturally Worn3
- Physical Resistance/Sticking2
- Difficult to Remove1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information6
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Structural Problem
It was reported that actis straight stem inserter not releasing from implant once impacted in.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802938 ↗MalfunctionJun 29, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE STRAIGHT STEM INSERTION WOULD NOT ENGAGE INTO THE HANDLE, IT LOOKED TO BE BENT OUT OF POSITION, ALL OTHER STEM INSERTION INSTRUMENTS ENGAGED INTO THE HANDLE WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659665 ↗MalfunctionJun 24, 2026Material Deformation
IT WAS REPORTED THAT ACTIS STRAIGHT INSERTER SHAFT IS SLIGHTLY DAMAGED; BENT. IT WAS NOTICED BY SURGEON. PATIENT WAS NOT AFFECTED AND NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25605741 ↗MalfunctionJun 9, 2026Material Deformation
IT WAS REPORTED THAT ACTIS STRAIGHT INSERTER SHAFT IS SLIGHTLY DAMAGED; BENT. IT WAS NOTICED BY SURGEON. PATIENT WAS NOT AFFECTED AND NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443257 ↗MalfunctionMay 25, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING STERILE PROCESSING CSR EXAMINATION IT WAS OBSERVED THAT THE IMPACTOR COULD NOT FIT WITH THE HANDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270294 ↗MalfunctionMay 25, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING STERILE PROCESSING CSR EXAMINATION IT WAS OBSERVED THAT THE IMPACTOR COULD NOT FIT WITH THE HANDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270292 ↗MalfunctionApr 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE STRAIGHT ACTIS INSERTER BECAME LODGED IN THE LATERAL SHOULDER OF THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932063 ↗MalfunctionApr 1, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT TIP OF INSERTER HAD MUSHROOMED AND DID NOT INSERT RIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755212 ↗MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON NOTICING THAT AN ACTIS STRAIGHT INSERTER WAS GETTING STUCK IN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767500 ↗MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON NOTICED THAT ACTIS STRAIGHT INSERTER WAS GETTING STUCK IN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760195 ↗MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON NOTICING THAT ACTIS STRAIGHT INSERTER IS GETTING STUCK IN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758658 ↗MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON NOTICING THAT ACTIS STRAIGHT INSERTER WAS GETTING STUCK IN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758642 ↗MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM WAS STUCK IN UNIVERSAL IMPACTOR HANDLE. NEEDED TO MALLET TO GET IT DETACHED. IT WAS DAMAGED WHEN IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024896 ↗MalfunctionAug 25, 2025Break; Break
IT WAS REPORTED THAT THE ACTIS IMPLANT IMPACTOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22890160 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22803821 ↗MalfunctionJul 31, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT, DURING SURGERY, THE HANDLE COULD NOT BE SEPARATED FROM THE IMPACTOR. THIS DID NOT CAUSE ANY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22679572 ↗MalfunctionJul 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE STEM INSERTERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22577544 ↗MalfunctionJan 21, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE STRAIGHT ACTIS STEM INSERTER WAS NICKED AND HAS A BEND TO IT. SPD REQUESTED A REPLACEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21201553 ↗MalfunctionOct 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT UNIVERSAL HANDLE AND ACTIS STRAIGHT INSERTER STUCK TOGETHER.
Patient problems: Insufficient Information
MAUDE report 20461108 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19085337 ↗MalfunctionApr 10, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE INSERTER SHAFT AND THE UNIVERSAL STEM INSERT HANDLE. DURING SURGERY, THE INSERTER SHAFT AND THE HANDLE COULD NOT BE MATED. THE SURGEON FITTED THE INSTRUMENTS FORCEFULLY, AND THE SURGERY WAS PROCEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19078193 ↗MalfunctionApr 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON STATED STEM INSERTER WOULD NOT LOCK IN TO THE IMPLANT DURING IMPACTION.
Patient problems: Insufficient Information
MAUDE report 19069602 ↗MalfunctionFeb 29, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE TWO INSTRUMENTS BROKE DURING CASE. HAD BACKUPS AVAILABLE. THE TWO PIECES GOT STUCK TOGETHER. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18811903 ↗MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSERTER SHAFT WILL NOT PROPERLY ASSEMBLE TO MATING DEVICE TO HANDLE. NO DELAY.
Patient problems: Insufficient Information
MAUDE report 18610642 ↗MalfunctionDec 22, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE STRAIGHT INSERTION SHAFT IS SLIGHTLY BENT AT THE END AND NO LONGER IF FUNCTIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18388972 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.