EXPEDIUM 3010-19-003Recalls & reported problems
Medos International Sàrl · NAVIGATION ENABLED INSTRUMENTS EXPEDIUM DRIVER - SHAFT T20 5.5 · Class 2
All models of EXPEDIUM (291)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Expedium navigated surgical driver has 132 reports, most describing parts that break, bend or wear, such as shafts, sleeves and handles. Some describe a driver tip breaking off inside a screw. The reports mention 8 injuries and no deaths, and no recalls name this device. Reports fell to 7 in the last 12 months from 25 in the previous 12.
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
- 133
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10705034561387), received between Jan 15, 2021 and Sep 23, 2026 — classified as 8 injuries, 125 malfunctions.
The most frequently reported specific device problem is “Break” (95 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.
Reports received per month
Most reported problems
Device problems
- Break95
- Material Twisted/Bent37
- Device-Device Incompatibility16
- Entrapment of Device14
- No Apparent Adverse Event2
- Device Slipped1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- Foreign Body In Patient14
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873873 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT WHEN SURGEON, WORKING WITH VERY SCLEROTIC BONE, USED A MALLET ON NAVIGATED INSTRUMENTS, RESULTING IN THE HANDLE BREAKING. WHILE INSERTING A 100MM ILIAC CREST BOLT, HIGH SHEAR FORCES CAUSED THE TIP OF THE DRIVER TO BREAK OFF IN THE SCREW. THE SCREWDRIVER WAS REPLACED, AND THE INSERTED SCREW WAS REMOVED AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS DELAYED BY 10 MINUTES DUE TO THE EVENT, BUT WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421002 ↗MalfunctionDec 30, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE SHAFT BROKE AS WELL AS THE SLEEVE, THE MISSING CODE SHOULD HAVE BEEN ADDED AS WELL SINCE THE 2 PARTS GOES TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929314 ↗MalfunctionDec 30, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: THE SHAFT BROKE AS WELL AS THE SLEEVE, THE MISSING CODE SHOULD HAVE BEEN ADDED AS WELL SINCE THE 2 PARTS GOES TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929300 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVERS APPEAR TO BE WEARING AT THE DISTAL TIP AND NOT ENGAGING WITH SCREW HEAD FULLY. BUTTONS ON THE SLEEVES ARE BECOMING WORN AS WELL AND DRIVER T HANDLES ARE SQUEAKING MORE THAN USUAL AND DIFFICULT TO CONNECT TO SHAFT. ENTIRE DRIVER TOOL NEEDS REPLACING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587059 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVERS APPEAR TO BE WEARING AT THE DISTAL TIP AND NOT ENGAGING WITH SCREW HEAD FULLY. BUTTONS ON THE SLEEVES ARE BECOMING WORN AS WELL AND DRIVER T HANDLES ARE SQUEAKING MORE THAN USUAL AND DIFFICULT TO CONNECT TO SHAFT. ENTIRE DRIVER TOOL NEEDS REPLACING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587057 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVERS APPEAR TO BE WEARING AT THE DISTAL TIP AND NOT ENGAGING WITH SCREW HEAD FULLY. BUTTONS ON THE SLEEVES ARE BECOMING WORN AS WELL AND DRIVER T HANDLES ARE SQUEAKING MORE THAN USUAL AND DIFFICULT TO CONNECT TO SHAFT. ENTIRE DRIVER TOOL NEEDS REPLACING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586989 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREW DRIVERS APPEAR TO BE WEARING AT THE DISTAL TIP AND NOT ENGAGING WITH SCREW HEAD FULLY. BUTTONS ON THE SLEEVES ARE BECOMING WORN AS WELL AND DRIVER T HANDLES ARE SQUEAKING MORE THAN USUAL AND DIFFICULT TO CONNECT TO SHAFT. ENTIRE DRIVER TOOL NEEDS REPLACING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586987 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE EQUIPMENT WAS BROKEN. DURING A SPINE PROCEDURE. SURGERY WAS NOT DELAYED DUE TO THE EVENT AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389486 ↗MalfunctionJun 16, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STARS ON ONE INSTRUMENTS WAS NOT MOVING FREELY. A FEW THINGS WERE TRIED, BUT WAS NOTICED THAT IT WAS THE SCREWDRIVERS AND NOT THE STARS. THE STAR WAS PLACED ON ANOTHER INSTRUMENT AND IT WORKED PERFECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22213006 ↗MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NAVIGATION DRIVER 5.5MM 301019003 X2 HAS BECAME DULL AT THE TIP (REDACTED), NO CASE OR PATIENT IMPACTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21719973 ↗MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NAVIGATION DRIVER 5.5MM 301019003 X2 HAS BECAME DULL AT THE TIP (REDACTED), NO CASE OR PATIENT IMPACTED. NO PATIENT INVOLVEMENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21719970 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, DURING A HARDWARE REMOVAL IT WAS NOTICED THAT THE DRIVER TIP WAS ROUNDED OFF AND WAS SLIPPING IN THE HEAD OF THE SCREW. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DRIVER TIP WAS IN TACK. JUST ROUNDED AND WOULD NOT GRIP THE INSIDE OF THE SCREW. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620703 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, DURING A HARDWARE REMOVAL IT WAS NOTICED THAT THE DRIVER TIP WAS ROUNDED OFF AND WAS SLIPPING IN THE HEAD OF THE SCREW. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DRIVER TIP WAS IN TACK. JUST ROUNDED AND WOULD NOT GRIP THE INSIDE OF THE SCREW. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620653 ↗MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER HAS BECOME BLUNT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553619 ↗MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER HAS BECOME BLUNT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553605 ↗MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER HAS BECOME BLUNT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553600 ↗MalfunctionMar 6, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE DOCTOR WAS INSERTING AN S2 ALAR SCREW CROSSING INTO THE PELVIS AND ON HER FINAL TURN OF THE DRIVER, TIP OF DRIVER SHEARED OFF INTO THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE FRAGMENT GENERATED WAS RETAINED WITHIN THE SCREW. THE SURGEONS ATTEMPTED TO RETRIEVE THE FRAGMENT FROM THE SCREW BUT WERE UNSUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 21535136 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196647 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196550 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196512 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196473 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT DUE TO THE CANNULATION, THE DRIVER'S BREAK OFF AT THE END EASILY. MULTIPLE DRIVERS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196421 ↗MalfunctionJan 8, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE WORN AND STRIPPED. SURGERY WAS COMPLETED SUCCESSFULLY USING THE INSTRUMENTS, AND THERE WAS NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21105963 ↗MalfunctionDec 12, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED WHEN THE SURGEON WAS INSERTING THE S2 AI SCREW INTO THE PATIENT, THE DISTAL TIP OF THE SCREWDRIVER SHEARED OFF IN THE HEAD OF THE PEDICLE SCREW. THE SHEARED OFF FRAGMENT REMAINED IN THE HEAD OF THE SCREW AND THE SURGEON DID NOT REMOVE THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO CONSEQUENCE TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20916241 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page