NorthStar PC2-200014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981199579), received between Feb 17, 2026 and Feb 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Structural Problem” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Structural Problem

  DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2026, THE NORTHSTAR TORQUE LIMITING HANDLE BOUND DURING USE. THE DISTRIBUTOR REPRESENTATIVE REPORTED THAT THERE WAS NO BACKUP INSTRUMENT AVAILABLE, THEREFORE, THE SURGEON HAD TO PROCEED WITH MANUAL TIGHTENING AND COULD NOT CONFIRM WHETHER THE FINAL CONSTRUCT WAS TIGHTENED TO THE SPECIFIED TORQUE. ALTHOUGH NO PATIENT INJURY WAS REPORTED, THE INABILITY TO VERIFY THAT THE CONSTRUCT WAS TIGHTENED TO THE VALIDATED TORQUE SPECIFICATION MAY COMPROMISE CONSTRUCT STABILITY POST-OPERATIVELY. BASED ON THIS RISK AND THE POTENTIAL FOR PATIENT HARM, THE EVENT WAS DETERMINED TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369358 ↗