TRIGEN 71631418Recalls & reported problems
Smith & Nephew, Inc. · META-TAN LAG SCREW DRILL SLEEVE · Class 2
All models of TRIGEN (381)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556158425), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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
- Failure to Align1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Unstable; Failure to Align
IT WAS REPORTED THAT, DURING A THR SURGERY, A META-TAN LAG SCREW DRILL SLEEVE WAS LOOSE WITHIN THE META-TAN DROP. THE LOOSENESS CAUSED TO MUCH VARIANCE DURING THE GUIDE PIN INSERTION, WHICH ALLOWED THE GUIDE PIN TO MISS THE TARGETED NAIL. THE GUIDE PIN SHOT ANTERIOR TO THE NAIL APERTURE BUT ALSO WAS ABLE TO BE MANIPULATED TO HIT POSTERIOR AS WELL. THE PROCEDURE WAS SUCCESSFULLY RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN, BUT NO OTHER COMPLICATIONS WERE REPORTED, AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS NEEDED DUE TO THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434126 ↗
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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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