NavLock 9733734 (UDI 00643169089600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169089600), received between Sep 28, 2016 and Jul 17, 2025 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE RATCHET HANDLE HAD DETACHMENT ISSUES. THERE WAS NO IMPACT TO PATIENT'S OUTCOME AND SURGICAL DELAY WAS LESS THAN ONE-HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530374 ↗
• MalfunctionJun 3, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PARTS IN THE REAR PART OF THE RATCHET HANDLE HAD BECOME DETACHED DURING PRE-USAGE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137942 ↗
• MalfunctionJan 23, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BACK END OF THE RATCHETING HANDLE WHERE THEY CAN USE A HAMMER FOR THE AWL APPEARED TO HAVE SUNK INTO THE HAND OR THE PLATE FELL OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21222913 ↗
• MalfunctionJan 23, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BACK END OF THE RATCHETING HANDLE WHERE THEY CAN USE A HAMMER FOR THE AWL APPEARED TO HAVE SUNK INTO THE HAND OR THE PLATE FELL OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21222818 ↗
• MalfunctionJan 15, 2025Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS BREAKAGE TO THE INSTRUMENT FIXATION PART. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE INSTRUMENT FIXING PART OF THE HANDLE CAME OFF, SO THE INSTRUMENT COULD NOT BE GRASPED BY THE HANDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162389 ↗
• MalfunctionAug 5, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ONE OF THE STRAIGHT RATCHETING HANDLES IN THE INSTRUMENT TRACKER SET WAS BROKEN. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS LIKELY DUE TO DAILY USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912407 ↗
• MalfunctionJun 28, 2022Material Integrity Problem; Material Integrity Problem

  2022-JUN-24 00740686 (REP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RATCHET HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844166 ↗
• MalfunctionNov 18, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THE HANDLES WERE USED THROUGHOUT VARIOUS ASPECTS OF SPINAL PROCEDURES. AT TIMES, IT BECAME NECESSARY TO MALLET THE HANDLES IN AN EFFORT TO BREAK THROUGH SCLEROTIC BONE. IT WAS OBSERVED OVER TIME THAT THE METAL IMPACTION CAP ON THE TOP OF THE HANDLE BECAME LOOSE AND SOMETIMES COMPLETELY DETACHED. ONCE DETACHED, THE ABILITY TO EFFICACIOUSLY MALLET THE HANDLE WAS LOST. SINCE THE INTEGRITY OF THE HANDLE WAS COMPROMISED, PROPER SANITATION CANNOT BE COMPLETED FOR FURTHER USE IN NON-MALLETING SITUATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836641 ↗
• MalfunctionNov 18, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THE HANDLES WERE USED THROUGHOUT VARIOUS ASPECTS OF SPINAL PROCEDURES. AT TIMES, IT BECAME NECESSARY TO MALLET THE HANDLES IN AN EFFORT TO BREAK THROUGH SCLEROTIC BONE. IT WAS OBSERVED OVER TIME THAT THE METAL IMPACTION CAP ON THE TOP OF THE HANDLE BECAME LOOSE AND SOMETIMES COMPLETELY DETACHED. ONCE DETACHED, THE ABILITY TO EFFICACIOUSLY MALLET THE HANDLE WAS LOST. SINCE THE INTEGRITY OF THE HANDLE WAS COMPROMISED, PROPER SANITATION CANNOT BE COMPLETED FOR FURTHER USE IN NON-MALLETING SITUATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836640 ↗
• MalfunctionNov 18, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. THE HANDLES WERE USED THROUGHOUT VARIOUS ASPECTS OF SPINAL PROCEDURES. AT TIMES, IT BECAME NECESSARY TO MALLET THE HANDLES IN AN EFFORT TO BREAK THROUGH SCLEROTIC BONE. IT WAS OBSERVED OVER TIME THAT THE METAL IMPACTION CAP ON THE TOP OF THE HANDLE BECAME LOOSE AND SOMETIMES COMPLETELY DETACHED. ONCE DETACHED, THE ABILITY TO EFFICACIOUSLY MALLET THE HANDLE WAS LOST. SINCE THE INTEGRITY OF THE HANDLE WAS COMPROMISED, PROPER SANITATION CANNOT BE COMPLETED FOR FURTHER USE IN NON-MALLETING SITUATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836624 ↗
• MalfunctionDec 30, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MANUFACTURER REPRESENTATIVE CONFIRMED THAT THERE WAS NO SURGERY DELAY AND STATED THAT THEY NOTICED THAT THE HANDLE CAP WAS SHIFTING, AND INSTRUCTED THE HEALTH CARE PROFESSIONAL TO CHANGE THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095022 ↗
• MalfunctionDec 5, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION AND SPINAL INSTRUMENTS BEING USED INTRA-OPERATIVELY OF A SPINAL L4/5 STENOSIS PROCEDURE. IT WAS REPORTED THAT THE LEGACY RATCHET AND PROVISIONAL BREAK OFF. THE RATCHET HANDLE BROKE. THEY DID NOT BREAK INSIDE THE PATIENT ANATOMY. THERE WAS NO IMPACT ON THE PATIENT INCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ALL THREE INSTRUMENTS WERE ALL BROKEN. THE PROVISIONAL WOULD NO LONGER RETAIN THE BREAK OFF SCREWS. THE RATCHET HANDLES WERE NO LONGER WORKING. THE CAPS ON TOP FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950980 ↗
• MalfunctionFeb 13, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE IS DAMAGED OUT OF THEIR LOANER SET. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9706052 ↗
• MalfunctionJun 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SILVER TAP CAP WAS COMING OFF THE RATCHETING HANDLE. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8719903 ↗
• MalfunctionJun 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE WAS DAMAGED. THE UPPER METAL CAP WAS LOOSE AND LOST. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8714761 ↗
• MalfunctionMay 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE CAP CAME OFF THE HANDLE DURING STERILE PROCESSING. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8649344 ↗
• MalfunctionMay 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BACK OF THE RATCHETING HANDLE SILVER CAP CAME OFF. THIS WAS NOTICED WHEN INSPECTING THE INSTRUMENT TRAY. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8643246 ↗
• MalfunctionMay 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE RATCHETING STRAIGHT HANDLE BROKE APART. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS NO REPORTED SURGICAL DELAY. A SYSTEM CHECKOUT WAS PERFORMED AND FOUND THAT THE RATCHETING STRAIGHT HANDLE WAS REPLACED. A SYSTEM CHECKOUT WAS SUCCESSFULLY PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603879 ↗
• MalfunctionMar 18, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE NAVIGATE TASK OF A SPINAL FUSION PROCEDURE THAT THE SHOCK PLATE OF THE RATCHETING HANDLE BROKE OFF. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428313 ↗
• MalfunctionMar 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE RATCHETING HANDLE WAS BROKEN. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8407987 ↗
• MalfunctionFeb 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) WHO HAD RECEIVED INFORMATION FROM A HEALTHCARE PROVIDER (HCP) INDICATING THAT THE SCREWDRIVER HANDLE NEEDED TO BE REPLACED BECAUSE THE METAL CAP ON THE END OF THE SCREWDRIVER CAME OFF. THE ISSUE OCCURRED AFTER ANESTHESIA, BUT BEFORE INCISION IN A LUMBAR FUSION PROCEDURE. THERE WAS NO CHANGE IN PATIENT OUTCOME AND THERE WAS NO REPORTED DELAY IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375557 ↗
• MalfunctionFeb 1, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THREE OF THE SITES RATCHET HANDLES HAVE THE TOP SILVER PIECE MISSING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8297537 ↗
• MalfunctionDec 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SILVER END OF THE RATCHETING HANDLE WHERE THE SURGEON HAMMERS THE HANDLE HAD COME OFF. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8182661 ↗
• MalfunctionDec 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SILVER END OF THE RATCHETING HANDLE WHERE THE SURGEON HAMMERS THE HANDLE HAD COME OFF. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8182650 ↗
• MalfunctionNov 5, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT WHEN THE MANUFACTURER REPRESENTATIVE RECEIVED THE NAC NAVLOCK TRAY BACK, THE RATCHETING HANDLE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8039910 ↗