Navio PFSD01009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20885556628724), received between Apr 23, 2020 and Dec 2, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHEN CHECKING THE X-RAYS THE FOLLOWING DAY AFTER A NAVIO UKR PROCEDURE, IT WAS NOTED THAT TWO VERIFICATION CHECK PINS HAD BEEN LEFT IN THE PATIENT. THIS REPORT IS FOR THE SECOND PIN. BOTH PINS WERE REMOVED THREE DAYS POST-OPERATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10935895 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHEN CHECKING THE X-RAYS THE FOLLOWING DAY AFTER A NAVIO UKR PROCEDURE, IT WAS NOTED THAT TWO VERIFICATION CHECK PINS HAD BEEN LEFT IN THE PATIENT. THIS REPORT IS FOR THE FIRST PIN. BOTH PINS WERE REMOVED THREE DAYS POST-OPERATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10935859 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT DURING NAVIO TKA PROCEDURE WHILE PATIENT UNDER ANESTHESIA, DURING REMOVAL OF CHECKPOINT AT END OF SURGERY THE PIN BROKE IN HALF. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. NO DELAY, OR PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717926 ↗
• InjuryOct 19, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, DURING THE SECOND LEG OF A BILATERAL KNEE SURGERY USING THE NAVIO SURGICAL SYSTEM, THE SURGEON WANTED TO MAKE A CEMENTING AUGMENT AFTER FINAL LONG-LEG ALIGNMENT VERIFICATION. THE SURGEON USED ONE CHECKPOINT PIN TO ASSIST WITH THE CEMENT AUGMENTATION, ALTHOUGH THIS IS NOT THE USE FOR THIS REUSABLE DEVICE. THE SURGEON WAS ADVISED THAT THE CONSTRUCT WAS STAINLESS STEEL AND WAS NOT COMPATIBLE WITH THE COBALT CHROME COMPONENT. THE PIECE IS STILL IMPLANTED. IT IS UNKNOWN THE CURRENT STATUS OF THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701155 ↗
• MalfunctionApr 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT BEFORE SURGERY, IT WAS FOUND THAT THE TIP OF NAVIO CHECKPOINT VERIFICATION WAS BENDING AND BROKEN. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9990534 ↗