Navio PFSR110008Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556628560), received between Apr 22, 2020 and Apr 25, 2020 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (13 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING LAB/DEMO, ONE OF THE TRACKER CLAMPS WAS LOOSE AND NOT CLAMPING PROPERLY. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9999268 ↗
• InjuryApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING CASE HAD A TRACKER ARRAY MOVE DURING A CASE 4.6 MM. THE CLAMP USED WAS BRAND NEW AND MOVED 4.6 MM THE NEXT TIME IT WAS USED WHICH WAS REPORTED. THE CLAMP WAS USED ON THE TIBIA IN THIS CASE, THE EM TIBIA JIG WAS USED TO MAKE TIBIA CUT. NO PATIENT INJURY, OUTCOME EXACTLY AS PLANNED. DELAY OF LESS THAN 30 MINUTES WAS INVOLVED AND NO PATIENT INJURIES WERE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999218 ↗
• MalfunctionApr 24, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT BEFORE PROCEDURE THE TRACKER CLAMP WILL NOT OPEN OR CLOSE AND IT IS CONSIDERED INOPERABLE. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9998669 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TRACKER CLAMP WAS COMPLETELY UNSCREWED AFTER THE CASE RESULTING IN DAMAGE THAT IS UNABLE TO BE REPAIRED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988644 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE BONE PIN/TRACKER CLAMP KNURLED NUT WOULD EXTEND BEYOND STOP. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988621 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE KNURLED NUT EXTENDED BEYOND BUILT-IN STOP IN TRACKER CLAMPS. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988478 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE KNURLED NUT EXTENDED BEYOND BUILT-IN STOP IN TRACKER CLAMPS. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988459 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE KNURLED NUT EXTENDED BEYOND BUILT-IN STOP IN TRACKER CLAMPS. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988426 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE KNURLED NUT EXTENDED BEYOND BUILT-IN STOP IN TRACKER CLAMPS. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988369 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE KNURLED NUT EXTENDED BEYOND BUILT-IN STOP IN TRACKER CLAMPS. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988329 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO BONE PIN CLAMPS ARE EXTENDING BEYOND INTERNAL STOP. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987710 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO BONE PIN CLAMPS ARE EXTENDING BEYOND INTERNAL STOP. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987616 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BONE PIN CLAMP EXTENDS BEYOND INTERNAL STOP. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987473 ↗
• MalfunctionApr 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BONE PIN CLAMP EXTENDS BEYOND THE INTERNAL STOP. UNKNOWN AT WHICH POINT OF THE SURGERY THE EVENT HAPPENED. NO INJURY OR PATIENT IMPACT HAS BEEN CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987444 ↗