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Panta 2 Arthrodesis Nail System PAN-1010-0230Recalls & reported problems

Smith & Nephew, Inc. · TARGETING GUIDE · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556828878), received between Apr 7, 2025 and Jan 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Align4
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 28, 2026Failure to Align

    IT WAS REPORTED THAT DURING A TTC ARTHRODESIS SURGERY, THE MOST PROXIMAL TIBIAL SCREW HOLE OF THE TARGETING GUIDE WAS SLIGHTLY MISALIGNED. THE DRILL CONTACTED THE NAIL AND PREVENTED THE SCREW FROM BEING PLACED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24205402 ↗
  • MalfunctionAug 26, 2025Failure to Align; Failure to Align

    IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHILE USING A TARGETING GUIDE, WHENEVER THE NAIL WAS POSITIONED POSTERIORLY IN THE PATIENT, THE PROXIMAL SCREW COULD NOT BE PLACED AS INTENDED. THE MISALIGNMENT OF THE TARGETING GUIDE PREVENTED THE DRILL FROM FITTING PROPERLY, WHICH IN TURN DID NOT ALLOW INSERTION OF THE SCREW. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22895394 ↗
  • MalfunctionAug 26, 2025Failure to Align; Failure to Align

    IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHILE USING A TARGETING GUIDE, WHENEVER THE NAIL WAS POSITIONED POSTERIORLY IN THE PATIENT, THE PROXIMAL SCREW COULD NOT BE PLACED AS INTENDED. THE MISALIGNMENT OF THE TARGETING GUIDE PREVENTED THE DRILL FROM FITTING PROPERLY, WHICH IN TURN DID NOT ALLOW INSERTION OF THE SCREW. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22894578 ↗
  • MalfunctionAug 22, 2025Failure to Align; Failure to Align

    IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHILE USING A TARGETING GUIDE, WHEN THE NAIL WAS POSITIONED POSTERIORLY IN THE PATIENT, THE PROXIMAL SCREW COULD NOT BE PLACED AS INTENDED. THE MISALIGNMENT OF THE TARGETING GUIDE PREVENTED THE DRILL FROM FITTING PROPERLY, WHICH IN TURN DID NOT ALLOW INSERTION OF THE SCREW. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22878041 ↗
  • MalfunctionApr 7, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, AFTER IMPACTION OF THE NAIL, IT WAS DISCOVERED THAT A PIECE OF ONE (1) TARGETING GUIDE BROKE OFF FROM THE TOP. THERE WAS NO IMPACTION TO THE TARGETING GUIDE IN THE AREA IT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21793029 ↗

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Sources and updates

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