NA 2299-90-030Recalls & reported problems
Depuy Orthopaedics, Inc. · CAS HIP NAVIGATED MI INSERTER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295115298), received between Nov 21, 2017 and Oct 7, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2024. THE IMPACTOR HANDLE METAL STRIKE PLATE BROKE ON IMPACTION OF MALLET STRIKE. ALL FRAGMENTS WERE REMOVED. A DIFFERENT IMPACTOR WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384654 ↗MalfunctionOct 25, 2019Break; Break
IT WAS REPORTED THAT THE BOTTOM PIECE BUSTED OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241127 ↗MalfunctionMar 29, 2019Break; Break
IT WAS REPORTED THAT THE OFFSET CUP INSERTER WAS FOUND IN THE TRAY WITH A PIECE OF THE PLASTIC LOCKING CLIP BROKEN OFF. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465788 ↗MalfunctionOct 3, 2018Break; Break
IT WAS REPORTED THAT THE PLASTIC CLIPS BROKE OFF FROM THE HANDLE AND THE LOCKING MECHANISM WILL NOT WORK FOR ITEM # (B)(4). PRODUCT BROKE INTO 2 PIECES AND ALL PIECES WERE RETRIEVED AND THIS DID NOT CAUSE ANY DELAY IN THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7931842 ↗MalfunctionNov 21, 2017Break; Break
IT WAS REPORTED THAT THE IMPACTER TIP BROKE OFF WHILE BEING STRUCK WITH MALLET.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 7048113 ↗
Other PUSHER, SOCKET devices
- NA 2299-90-025Depuy Orthopaedics, Inc. · PUSHER, SOCKET9 reports
- PINNACLE 2218-10-054Depuy (Ireland) · PUSHER, SOCKET2 reports
- FIREBIRD SFS 51-7111Orthofix US LLC · PUSHER, SOCKET1 report
- PINNACLE 2218-10-056Depuy (Ireland) · PUSHER, SOCKET1 report
- PINNACLE 2218-10-058Depuy (Ireland) · PUSHER, SOCKET1 report
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.
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