ORTHOPILOT NP621RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653331727), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

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.

• InjuryNov 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NP621R - ORTHOPILOT BICORTICAL SCREW 35MM. ACCORDING COMPLAINT DESCRIPTION A (B)(6) FEMALE PATIENT WHO UNDERWENT TKA USING ORTHOPILOT ON (B)(6) 2020, FELL AND SUFFERED AN OBLIQUE FRACTURE OF THE FEMORAL SHAFT. THE ONSET OF THE FRACTURE WAS OBSERVED IN THE VICINITY OF THE SCREW HOLE IN THE FEMEUR THAT WAS MADE USING A BICORTICAL SCREW. CT SCAN EXAMINATION REVEALED A FRACTURE LINE RUNNING FROM THE SCREW HOLE . THE SURGEON STATED THAT CAUSE OF THE POST OPERATIVE FRACTURE IS OBVIOUSLY THE PATIENT'S FALL, BUT THAT THE FEMEUR MIGHT HAVE BEEN MORE VULNERABLE TO FRACTURE AS A RESULT OF THE HOLE. REVISION IS SCHEDULE TO REINFORCE THE FEMEUR USING A PLATE. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 10792890 ↗