Navio PFSD01008Recalls & reported problems
Smith & Nephew, Inc. · Navio Bone Pin 4.0mm x 127mm · Class 2
All models of Navio (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The Navio Bone Pin is a surgical pin used with the Navio robotic system to hold bone in place during knee and hip procedures. Most of the 57 reports describe pins breaking, chipping at the tip, bending, or losing their threading, sometimes during surgery and sometimes found at setup. 17 reports are categorized as injuries and 40 as malfunctions, with no deaths reported. One report describes a patient falling and fracturing the femur at the pin insertion point. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00885556628737), received between Oct 30, 2019 and Nov 10, 2021 — classified as 17 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (16 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
Device problems
- Break16
- Defective Component16
- Inadequacy of Device Shape and/or Size6
- Material Twisted/Bent6
- Fracture5
- Naturally Worn3
- Unstable2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient20
- No Patient Involvement16
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions9
- Bone Fracture(s)1
- Fall1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2021Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DURING A NAVIO ASSISTED TKA SURGERY, WHILE REMOVING THE BONE PINS AFTER ALL PROCEDURES, IT WAS FOUND THAT ONE NAVIO BONE PIN 4.0MM X 127MM BROKE OFF AND OTHER ONE WAS DEFORMED. NO PIECES WERE LEFT INSIDE THE PATIENT (CONFIRMED USING C-ARM). THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12788232 ↗InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A NAVIO ASSISTED JOURNEY II SURGERY WAS PERFORMED ON (B)(6)-2021, THE PATIENT FELL AND A SUPRACONDYLAR FRACTURE OF THE FEMUR OCCURRED AT THE NAVIO BONE PIN 4.0MM X 127MM INSERTION POINT. A REVISION SURGERY WILL BE PERFORMED ON (B)(6)2021 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Bone Fracture(s); Fall
MAUDE report 12561119 ↗MalfunctionJul 29, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED TKA SURGERY, IT WAS FOUND THAT THE TIP OF THE NAVIO BONE PIN 4.0MM X 127MM WAS CHIPPED. 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 12250096 ↗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 (CASE (B)(4)), THE NAVIO BONE PIN 4.0MM X 127MM (CASE (B)(4)) AND THE NAVIO HANDPIECE THUMBERSCREW (CASE (B)(4)) HAD LOST THE THREADING. 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 12203381 ↗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 12114826 ↗MalfunctionJun 14, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING A NAVIO-ASSISTED TKA SURGERY, IT WAS FOUND THAT THE TIP OF THE NAVIO BONE PIN 4.0MM X 127MM WAS CHIPPED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11992352 ↗InjuryMay 11, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING A NAVIO TKA PROCEDURE, THREE BONE PINS BROKE INSIDE THE PATIENT DURING USE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11806288 ↗InjuryMay 7, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING A NAVIO TKA PROCEDURE, THREE BONE PINS BROKE INSIDE THE PATIENT DURING USE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794810 ↗InjuryMay 7, 2021Fracture; Fracture
IT WAS REPORTED THAT, DURING A NAVIO TKA PROCEDURE, THREE BONE PINS BROKE INSIDE THE PATIENT DURING USE. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794746 ↗MalfunctionNov 20, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT, DURING A NAVIO DEMO, THE PIN WAS BENT. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10874821 ↗MalfunctionNov 18, 2020Break; Break
IT WAS REPORTED THAT AFTER UNKNOWN NAVIO PROCEDURE THE PIN WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10863570 ↗MalfunctionNov 13, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT, DURING NAVIO TKA PROCEDURE, WHEN DRILLING BONE PIN, THE SURGEON REALIZED IT WAS BENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN EQUIPMENT SWAP. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10835817 ↗MalfunctionJul 10, 2020Naturally Worn; Naturally Worn
IT WAS REPORTED THAT AFTER A UKR PROCEDURE, THE SPD FOUND THAT A LONG 4.0 X 127 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 10260561 ↗MalfunctionApr 30, 2020Break; Break
IT WAS REPORTED THAT AFTER THE SURGERY, DURING THE WASHING OF THE INSTRUMENTS, IT WAS FOUND THAT THE PIN OF THE BONE PIN WAS BROKEN. NO CASE INVOLVED (THERE WAS NO HARM TO PATIENTS).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10015715 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9999766 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9999765 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9999764 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9999763 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT THE BONE PIN IS SLIGHTLY BENT. AS THIS WAS NOTICED BEFORE SURGERY, UPON INSPECTION, THE PATIENT WAS NOT INVOLVED AT THE MOMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10000400 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BONE SCREW WAS NOTICED AS BENT AND WOBBLY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10000397 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BONE SCREW WAS NOTICED AS BENT AND WOBBLY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10000392 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BONE SCREW WAS NOTICED AS BENT AND WOBBLY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10000391 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10000386 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10000384 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
IT WAS REPORTED THAT BONE SCREW WAS FOUND DEFORMED. AS THIS WAS NOTICED UPON INSPECTION, NO CASE WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10000383 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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