NA 9200-10-029Recalls & reported problems
Depuy (Ireland) · DePuy MI System ANGLED ACET INSERTER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy MI angled acetabular inserter is a surgical tool used to seat the socket cup during hip replacement surgery. Its 741 reports, all malfunctions, mostly describe the handle cracking or breaking, and some describe parts that will not lock or mount properly. The reports include no deaths or injuries. 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
- 745
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 745 adverse event reports that list this exact device (DI 10603295221890), received between Jul 7, 2017 and Sep 25, 2026 — classified as 745 malfunctions.
The most frequently reported specific device problem is “Break” (509 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break509
- Crack210
- Device-Device Incompatibility74
- Naturally Worn23
- Component Missing19
- Mechanical Jam17
- Material Deformation12
- Material Twisted/Bent9
Patient problems
- No Clinical Signs, Symptoms or Conditions457
- No Consequences Or Impact To Patient221
- Insufficient Information46
- No Information22
- No Code Available19
- Not Applicable7
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 745 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility; Material Integrity Problem
It was reported that the modular tip was damaged and would not easily attach to impactor handle. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898870 ↗MalfunctionSep 10, 2026Break
It was reported that the event did not happen in surgery. The spring was broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716441 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572572 ↗MalfunctionSep 2, 2026Break
It was reported that during a surgical procedure of the hip it was observed that the instrument broke. It was reported that the handle had broken. It was reported that nothing was left inside the patient, and there were no delays to the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555275 ↗MalfunctionAug 31, 2026Crack
It was reported that during in-house engineering evaluation, it was determined that ANGLED ACET INSERTR was Broken (2+ Pieces) : Handle. It was initially reported that the instruments had an unknown allegation. The black handle cracked as they were all due over time. It did not happen in surgery. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525537 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302880 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227812 ↗MalfunctionAug 3, 2026Break
It was reported that during impaction of acetabular cup, the pinnacle offset impactor handle cracked. All pieces retrieved. No delay. No complications. The device will be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117497 ↗MalfunctionJun 2, 2026Crack
IT WAS REPORTED THAT A CRACK DEVELOPED IN THE HANDLE OF THE ANGLED CUP INSERTER UPON IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363001 ↗MalfunctionMay 28, 2026Break
IT WAS REPORTED THAT HANDLE CHIPPED IN SURGERY DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317023 ↗MalfunctionMay 21, 2026Crack
IT WAS REPORTED THAT A CRACK DEVELOPED IN THE HANDLE OF ANGLED CUP INSERTER UPON IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241732 ↗MalfunctionMay 13, 2026Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT UPON INSPECTION, INSTRUMENT WAS DAMAGED AND WOULD NOT LOCK. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164331 ↗MalfunctionMay 13, 2026Mechanical Jam
IT WAS REPORTED THAT THE DISTAL TIP WAS STUCK AND WOULD NOT LOCK THE THREADED TIP ON. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164048 ↗MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT THE SURGEON BROKE THE HANDLE WHILE IMPACTING CUP. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123050 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT THE DEVICE BROKE. THERE WERE NO DELAYS TO SURGERY AND NOTHING WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048434 ↗MalfunctionApr 20, 2026Break; Crack
IT WAS REPORTED THAT THE INSTRUMENT HANDLE WAS CRACKED AND BROKEN. IT WAS REMOVED BEFORE THE PATIENT ENTERED THE ROOM. ALSO A 25 MM DRILL BIT DEVICE WAS BENT DURING THE CASE. NOTHING FROM THE INSTRUMENT BROKE OFF OR WAS LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924951 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT OFFSET IMPACTOR PLASTIC BROKE WHILE IMPACTING. PATIENT CARE WAS NOT AFFECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886308 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT THE BLACK INSERTER TIP BROKE WHEN USING OFFSET HANDLE TO IMPACT CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885708 ↗MalfunctionApr 13, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR TIP WOULD NOT SNAP ON TO THE END OF THE IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865901 ↗MalfunctionApr 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY (THA), AFTER CONNECTING THE TRIAL CUP, THE TIP WAS MORE FIRMLY FIXED THAN USUAL, MAKING IT DIFFICULT TO DETACH. THE SURGEON USED A SPARE HANDLE TO RESOLVE THE ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845111 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THE BLACK PLASTIC CASING ON THE HANDLE HAS SNAPPED- THIS SEEMS TO BE AN ONGOING ISSUE. THERE WERE NO DELAYS TO SURGERY AND NOTHING WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755260 ↗MalfunctionMar 31, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE MODULAR TIP OF ANGLED CUP INSERTER GETS STUCK. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742114 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT THE ANGLE CUP INSERTER HANDLE, WHICH HAD BEEN USED IN OVER 75 HIP SURGERIES, HAD THE HANDLE PART COMPLETELY BROKEN OFF AND REQUIRED REPLACEMENT AFTER A HIP SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673975 ↗MalfunctionMar 18, 2026Crack
IT WAS REPORTED THAT THE BLACK CUP HANDLE IS CRACKED, THE REAMER SHAFT IS BROKEN ON REAMER. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631165 ↗MalfunctionMar 10, 2026Crack
IT WAS REPORTED THAT THE PLASTIC HANDLE OF ANGLED CUP INSERTER CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563208 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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