Panta 2 Arthrodesis Nail System PAN-1010-0012Recalls & reported problems
Smith & Nephew, Inc. · REAMER. DIAMETER 12MM · Class 1
Data updated Oct 18, 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 00885556828595), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
MalfunctionApr 16, 2026Fracture
IT WAS REPORTED THAT, DURING A TIBIOTALAR CALCANEAL ARTHRODESIS, THE HEAD OF ONE (1) REAMER. DIAMETER 12MM HAD METAL FRAGMENTS PEELING OFF. IT WAS THEN DISCOVERED THAT PART OF THE METAL FRAGMENTS WERE STILL IN THE PATIENT'S PLANTAR TISSUE. THE SURGEON SUCCESSFULLY RECOVERED THE METAL FRAGMENTS FROM THE TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901430 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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