NAVIO ROB00004Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556685068), received between Apr 25, 2020 and Apr 27, 2020 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT A PLATE PROBE HAD A FIT ISSUE, IT COULD NOT BE LOCKED INTO THE COLLET AND WAS TIGHT WHEN REMOVING IT. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999762 ↗
• MalfunctionApr 26, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED 3 ADDITIONAL VISUALIZATION PLANE CHECKER TOOLS AND NONE OF THEM WILL LOCK ON TO HANDPIECES. SCRUB TECH ATTEMPTED ALL 3 NEW PLANE CHECKERS AND THEY ALMOST FIT BUT THE COLLAR WOULD NOT SEAT DOWN. REP ALSO TRIED OUTSIDE OF THE STERILE FIELD. NAVIO TKA BACK-UP TRAY WAS OPENED, USED A PLANE CHECKER AND IT LOCKED ON WITH NO PROBLEM ON TO THE SAME HANDPIECE. NO PATIENT INVOLVED SINCE THE EVENT OCCURS BEFORE TKA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 9999499 ↗
• MalfunctionApr 26, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED 3 ADDITIONAL VISUALIZATION PLANE CHECKER TOOLS AND NONE OF THEM WILL LOCK ON TO HANDPIECES. SCRUB TECH ATTEMPTED ALL 3 NEW PLANE CHECKERS AND THEY ALMOST FIT BUT THE COLLAR WOULD NOT SEAT DOWN. REP ALSO TRIED OUTSIDE OF THE STERILE FIELD. NAVIO TKA BACK-UP TRAY WAS OPENED, USED A PLANE CHECKER AND IT LOCKED ON WITH NO PROBLEM ON TO THE SAME HANDPIECE. NO PATIENT INVOLVED SINCE THE EVENT OCCURS BEFORE TKA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 9999486 ↗
• MalfunctionApr 26, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE ACCOUNT RECEIVED 3 ADDITIONAL VISUALIZATION PLANE CHECKER TOOLS AND NONE OF THEM WILL LOCK ON TO HANDPIECES. SCRUB TECH ATTEMPTED ALL 3 NEW PLANE CHECKERS AND THEY ALMOST FIT BUT THE COLLAR WOULD NOT SEAT DOWN. REP ALSO TRIED OUTSIDE OF THE STERILE FIELD. NAVIO TKA BACK-UP TRAY WAS OPENED, USED A PLANE CHECKER AND IT LOCKED ON WITH NO PROBLEM ON TO THE SAME HANDPIECE. NO PATIENT INVOLVED SINCE THE EVENT OCCURS BEFORE TKA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 9999479 ↗
• MalfunctionApr 26, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PROBLEM WITH THE TOOL WAS FOUND IN THE WAREHOUSE, THE NOTCHES WERE PREVENTING THE PLATE PROBES FROM PROPERLY LOCKING INTO THE HANDPIECE. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999475 ↗
• MalfunctionApr 26, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSPECTION, THE PLANE VERIFICATION TOOL FROM TKA TRAY WAS DIFFICULT TO SLIDE AND LOCK INTO THE MULTIPLE NAVIO HANDPIECES. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999466 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE VISUALIZATION TOOL WAS STUCK ON THE HAND PIECE AND WOULD NOT COME OFF. WE HAD NOTICED THIS PIECE NOT COMING ON OR OFF VERY WELL BUT THEY COULD NOT GET IT TO DISENGAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999465 ↗
• MalfunctionApr 26, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSPECTION, THE PLANE VERIFICATION TOOL FROM TKA TRAY WAS DIFFICULT TO SLIDE AND LOCK INTO THE MULTIPLE NAVIO HANDPIECES. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999464 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999433 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999425 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999423 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999403 ↗
• MalfunctionApr 26, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9999401 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PLATE PROBES NEED TO BE REPLACED DUE TO FIT ISSUES. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999308 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PLATE PROBES NEED TO BE REPLACED DUE TO FIT ISSUES. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999307 ↗
• MalfunctionApr 25, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PLATE PROBES NEED TO BE REPLACED DUE TO FIT ISSUES. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999292 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PLANE VISUALIZATION TOOL FOR NEEDS TO BE REPLACED BECAUSE THEY ARE ALL SNUG OR GET STUCK WHEN AFFIXING THEM TO THE HANDPIECE WITH THE DRILL INSERTED. DRILLS NEED TO BE REMOVED IN ORDER TO PROPERLY ATTACH. NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9999244 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE RECEPTACLE WHERE THE VISUALIZATION TOOL SLIDES AND LOCKS ONTO THE HANDPIECE SEEN AS OFF-CENTERED CAUSING THE HANDPIECE TO BECOME STUCK AND DIFFICULT TO REMOVE. LESS THAN 30 MINUTES DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9999192 ↗
• MalfunctionApr 25, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PLATE PROBE HAD A FIT ISSUE, IT COULD NOT BE LOCKED INTO THE COLLET AND WAS TIGHT WHEN REMOVING IT. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9999115 ↗