JOURNEY II UK 74036108Recalls & reported problems
Smith & Nephew, Inc. · POSTERIOR FEMORAL PEG DRILL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556696361), received between Sep 27, 2022 and Feb 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Disintegration” (3 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
- Material Disintegration3
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2023Material Disintegration; Mechanical Jam; Material Disintegration; Mechanical Jam
IT WAS REPORTED THAT, DURING A JOURNEY II UK PARTIAL KNEE REPLACEMENT SURGERY, THE POSTERIOR FEMORAL PEG DRILL BIT WAS BINDING IN THE 2-1 AP CUTTING GUIDE, CAUSING METAL FRETTING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278190 ↗MalfunctionJan 30, 2023Material Disintegration; Mechanical Jam; Material Disintegration; Mechanical Jam
IT WAS REPORTED THAT, TWO (2) POSTERIOR FEMORAL PEG DRILL JAMMED IN CUT BLOCK AND CREATED METAL DEBRIS. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16268431 ↗MalfunctionSep 27, 2022Material Disintegration; Material Disintegration
IT WAS REPORTED THAT, AFTER DRILLING IN A TKA SURGERY, METAL SHAVINGS COULD BE SEEN ON THE POSTERIOR FEMORAL PEG DRILL, POSSIBLY DUE TO WEAR OR HARD BONE. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED, WITHOUT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491881 ↗
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- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
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- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 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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