NAVIO ROB00031Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556685310), received between Jul 10, 2020 and Mar 9, 2022 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED SURGERY, WHEN DRILLING THE NAVIO BONE PIN 4.0MMX152MM INTO THE PATIENT'S FEMUR, THE SURGEON APPEARED TO STRUGGLE. HE REMOVED THE PIN TO REPOSITION AND THE PIN WAS NOTICED TO BE BENT. THE SURGEON USED ANOTHER PIN TO POSITION THE ARRAY AND CONTINUE THE SURGERY. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED DUE TO THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716164 ↗
• InjuryDec 23, 2021Break; Break

  IT WAS REPORTED THAT AT THE END OF A TKA SURGERY, THE NAVIO BONE PIN 4.0MMX152MM FAILED JUST ABOVE THE BLACK RING. FROM THE PHOTO PROVIDED, IT WAS NOTICED BROKEN AT THE TOP. IT HAPPENED WHILE IN USE INSIDE THE PATIENT AND THERE WAS NO NEED OF BACK-UP. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080449 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED PFA SURGERY, THE END OF THE NAVIO BONE PIN 4.0MMX152MM SHEARED OFF. INCIDENT OCCURRED WHILE INSTRUMENT WAS INSIDE THE PATIENT AND ALL THE PIECES WERE REMOVED USING FORCEPS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446906 ↗
• MalfunctionJul 28, 2021Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED SURGERY, THE NAVIO BONE PIN 4.0MMX152MM WAS BENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE BONE PINS FROM THE OTHER SET. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243538 ↗
• MalfunctionJul 21, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, DURING MACHINE SET UP FOR A NAVIO-ASSISTED SURGERY, IT WAS FOUND THAT THE NAVIO BONE PIN 4.0MMX152MM (B)(4), THE NAVIO BONE PIN 4.0MM X 127MM (B)(4) AND THE NAVIO HANDPIECE THUMBERSCREW (B)(4) HAD LOST THE THREADINGS. NO DELAYS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203367 ↗
• MalfunctionJul 5, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING SET UP FOR A NAVIO ASSISTED SURGERY, IT WAS NOTICES THAT NAVIO BONE PIN 4.0MMX152MM (CASE-(B)(4)), NAVIO BONE PIN 4.0MM X 127MM (CASE-(B)(4)) AND NAVIO HANDPIECE THUMBERSCREW (CASE-(B)(4)) HAD LOST THEIR THREADINGS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114824 ↗
• MalfunctionJun 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO-ASSISTED SURGERY, IT WAS FOUND THAT THE NAVIO BONE PIN 4.0MMX152MM WAS BROKEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921261 ↗
• MalfunctionMay 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE STERILE PROCESS THE NAVIO RI BONE PIN 4 MM X 152 MM WAS BENT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846726 ↗
• MalfunctionDec 8, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A NAVIO TKA PROCEDURE, THE SURGEON DECIDED TO QUICKLY USE THE BONE PIN DRIVER WITH BONE PINS FOR FEMUR AND DID NOT USE TISSUE PROTECTOR. AFTER THE CASE WAS FINISHED AND THE SURGEON TOOK NAVIO BONE PINS OUT OF FEMUR, ONE WAS BENT. THERE WERE NO DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971802 ↗
• MalfunctionOct 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A NAVIO TKA PROCEDURE, WHEN DRILLING THE BOX, THE SURGEON HIT THE FEMORAL BONE PIN. THIS DAMAGED THE BONE PIN (BENT) MAKING IT UNUSABLE (IT WAS NO LONGER REQUIRED EITHER). IT DID NOT NEGATIVELY AFFECT THE CASE (THERE WERE NO DELAYS AND NO INJURIES). NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680633 ↗
• MalfunctionJul 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NAVIO BONE PIN BENT WHEN DRIVING INTO BONE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10278055 ↗
• MalfunctionJul 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NAVIO BONE PIN BENT WHEN DRIVING INTO THE BONE. THE PROCEDURE WAS CONTINUED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10278010 ↗
• MalfunctionJul 13, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A LAB/DEMO, THE LONG BONE PINS THAT WERE USED IN THE FEMUR BROKE WHEN THEY WERE TRYING TO REMOVE THEM. THE TIP THAT CONNECTS TO THE PIN DRIVER BROKE. THEY BOTH SEEMED PRETTY USED AND DULL. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10268810 ↗
• MalfunctionJul 13, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A LAB/DEMO, THE LONG BONE PINS THAT WERE USED IN THE FEMUR BROKE WHEN THEY WERE TRYING TO REMOVE THEM. THE TIP THAT CONNECTS TO THE PIN DRIVER BROKE. THEY BOTH SEEMED PRETTY USED AND DULL. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10268809 ↗
• MalfunctionJul 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER A UKR PROCEDURE, THE SPD FOUND THAT A LONG 4.0 X 152 NAVIO BONE PIN WITH BROKEN THREADS AND WORN DOWN. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10260556 ↗
• MalfunctionJul 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER A UKR PROCEDURE, THE SPD FOUND THAT A LONG 4.0 X 152 NAVIO BONE PIN WITH BROKEN THREADS AND WORN DOWN. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10260526 ↗