JOURNEY 74014461Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II EXTRAMEDULLARY ALIGNMENT TUBE · Class 1
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556237892), received between Jan 21, 2020 and Aug 6, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Connection Problem1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2021Break; Break
IT WAS REPORTED THAT, THE LOCKING MECHANISM OF A JRNY II ALIGNMENT TUBE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12291547 ↗MalfunctionJul 15, 2021Break; Break
IT WAS REPORTED THAT, DURING SET-UP OF TOTAL KNEE ARTHROPLASTY SURGERY, A JOURNEY II ALIGNMENT TUBE WAS NOTICED TO BE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12171081 ↗MalfunctionMay 20, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT, DURING A SET UP FOR A TKA SURGERY, THE JII XR TIB NON-SPIKED FIX ROD CASE (B)(4) WAS NOT ABLE TO FULLY GO THROUGH THE JRNY II ALIGNMENT TUBE CASE (B)(4) AND WOULD GET STUCK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11858146 ↗MalfunctionJan 21, 2020Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING SURGERY, THE TWO INSTRUMENTS WON'T COME APART FOR CLEANING. IT CAUSED A DELAY OF 30 MINUTES TO AN HOUR. THERE WAS AN S&N BACKUP DEVICE AVAILABLE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9610647 ↗
Other Guide, surgical, instrument devices
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- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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