Panta 2 Arthrodesis Nail System PAN-1010-0016Recalls & reported problems
Smith & Nephew, Inc. · REAMER. DIAMETER 12.5MM · 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 00885556828632), received between May 15, 2024 and May 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
- Material Twisted/Bent1
- Peeled/Delaminated1
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.
MalfunctionMay 15, 2024Material Fragmentation; Peeled/Delaminated; Material Twisted/Bent; Material Fragmentation; Peeled/Delaminated; Material Twisted/Bent
IT WAS REPORTED THAT, DURING A TTC ARTHRODESIS, AFTER REAMING THE TIBIA, THE SURGICAL TECH WAS REMOVING BONE FROM THE CUTTING FLUTES OF THE REAMER. DIAMETER 12.5MM AND NOTICED THAT SOME OF THE EDGES OF CUTTING SURFACES HAD BEGUN TO PEEL AWAY. NO FURTHER REAMING WAS NECESSARY AND THE PROCEDURE WAS PERFORMED WITHOUT ANY INTERRUPTION. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE. THE REAMER IS NO LONGER OPERABLE FOR FUTURE CASES, AS THERE IS A RISK THAT THE SHARDS ARE TO COME OFF INSIDE THE TIBIA AND COULD BE TRICKY TO REMOVE AND POTENTIALLY CAUSE A RE-OPERATION IF SYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19327245 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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