Snowden-Pencer SP8368Recalls & reported problems
Steris Corporation · MARYLAND ERGONOMIC MODULAR 5MM,36CM,ESU INSERT · Class 2
All models of Snowden-Pencer (62)
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 10885403171994), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionJan 28, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE WITH THEIR SNOWDEN-PENCER MARYLAND DISSECTOR INSERT THE PIN THAT HOLDS THE ROD AND JAW TOGETHER "CAME OUT". THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING AN ADDITIONAL DEVICE. REPORT OF PROCEDURE DELAY. NO REPORT OF INJURY. THE PATIENT RECEIVED MEDICAL INTERVENTION (X-RAYS) FOLLOWING THE REPORTED EVENT AS A PRECAUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203868 ↗
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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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