TRIALTIS 5161-00-5046Recalls & reported problems
Medos International Sàrl · TRIALTIS Spine System Set Screw Tightener,T27 Long · Class 1
All models of TRIALTIS (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This TRIALTIS set screw tightener is a tool used in spine surgery to tighten screws. The 26 reports mostly describe the tool bending, warping or wearing out with repeated use, including stripped or worn tips found during inspection and one break that left fragments that were removed. The reports mention no deaths and no injuries. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705034592268), received between Sep 17, 2024 and Sep 4, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (22 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent22
- Material Deformation11
- Break2
- Entrapment of Device1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616764 ↗MalfunctionJun 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF FINAL TIGHTENERS ARE WORN DUE TO REPEATED USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456188 ↗MalfunctionJun 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF FINAL TIGHTENERS ARE WORN DUE TO REPEATED USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456187 ↗MalfunctionJun 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF FINAL TIGHTENERS ARE WORN DUE TO REPEATED USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456184 ↗MalfunctionJun 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIPS OF FINAL TIGHTENERS ARE WORN DUE TO REPEATED USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456181 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2026 WHEN INSPECTING THE TRAY AFTER DECONTAMINATION, BEFORE STERILIZATION, THE REPORTER DISCOVERED THAT THE SET SCREW TIGHTENERS BOTH SHOWED SIGNS OF STRIPPING. THE EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25171858 ↗MalfunctionMay 14, 2026Material Twisted/Bent
IT WAS REPORTED ON (B)(6) 2026 WHEN INSPECTING THE TRAY AFTER DECONTAMINATION, BEFORE STERILIZATION, THE REPORTER DISCOVERED THAT THE SET SCREW TIGHTENERS BOTH SHOWED SIGNS OF STRIPPING. THE EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25171747 ↗MalfunctionFeb 6, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS WORN DUE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281455 ↗MalfunctionJan 15, 2026Mechanical Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SURGEON STRIPPED THE DRIVER; IT WOULD NOT FINAL TIGHTEN. NO DELAY IN SURGERY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24084776 ↗MalfunctionSep 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AUGUST 28, 2025, DEVICE BECAME BENT/DAMAGED UPON INSERTION OF SET SCREW. STRIPPED DRIVER NOTICED AFTER CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058238 ↗MalfunctionSep 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON (B)(6) 2025, DEVICE BECAME BENT/DAMAGED UPON INSERTION OF SET SCREW. STRIPPED DRIVER NOTICED AFTER CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058204 ↗MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PRODUCT WAS STRIPPED/DAMAGED UPON TIGHTENING OF SET SCREW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23009484 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817005 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817004 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816995 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816991 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816989 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816983 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816982 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816981 ↗MalfunctionAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS WERE TWISTED, THE 5/6/7 TAPS WERE BENT, AND THE COMPRESSOR AND DISTRACTOR WERE MISSING LOCKING PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816979 ↗MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER TIPS TWISTED, 5/6/7 TAPS BENT, COMPRESSOR AND DISTRACTOR MISSING LOCKING PARTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809917 ↗MalfunctionOct 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2024 TWO T27 TRIALTIS FINAL TIGHTENERS WAS STRIPPED BY THE DR AT THE HOSPITAL. THE SALES REP WAS NOT CLOSE ENOUGH TO THE FIELD TO KNOW FOR SURE WHAT HAPPENED, BUT HIS BELIEF WAS THAT THE DRIVER WAS NOT FULLY ENGAGED INTO THE END OF THE SET SCREW BEFORE HE STARTED TO TORQUE. HE ALSO COMMENTED THAT HE BELIEVED ONE OF THE HEADS OF A TRIALTIS CORTICAL FIX SOLID SCREW WAS STARTING TO SPLAY DURING FINAL TIGHTENING. DURING THE CASE THEY NEEDED TO CUT A ROD. WE USED THE NEW TIRALTIS ROD CUTTER, AFTER CUTTING THE ROD THE ROD CUTTER WOULD NOT OPEN TO CUT ANOTHER ROD. AFTER THE CASE HE INSPECTED THE ROD CUTTER AND THERE APPEARED TO BE METAL ON METAL SCRAPING THAT IS NOT ALLOWING THE INSTRUMENT TO BE USED CORRECTLY. HE INSPECTED THE FINAL TIGHTENERS AND THE DISTAL END OF THE DRIVE MECHANISM SHOWED SIGNS OF STRIPPING AND THEY WERE DISCARDED FOLLOWING THE CASE. HE ALSO MENTIONED THAT THE TRIALTIS GREY TORQUE HANDLE WAS NOT PERFORMING UP TO HIS STANDARDS SET PRIOR BY OUR VERSE AND EXPEDIUM FINAL TIGHTENERS. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THEY USED ANOTHER FINAL TIGHTENER DRIVER AND HAD TO USE ANOTHER ROD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456625 ↗MalfunctionOct 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON 10/08/2024 TWO T27 TRIALTIS FINAL TIGHTENERS WAS STRIPPED BY THE DR AT THE HOSPITAL. THE SALES REP WAS NOT CLOSE ENOUGH TO THE FIELD TO KNOW FOR SURE WHAT HAPPENED, BUT HIS BELIEF WAS THAT THE DRIVER WAS NOT FULLY ENGAGED INTO THE END OF THE SET SCREW BEFORE HE STARTED TO TORQUE. HE ALSO COMMENTED THAT HE BELIEVED ONE OF THE HEADS OF A TRIALTIS CORTICAL FIX SOLID SCREW WAS STARTING TO SPLAY DURING FINAL TIGHTENING. DURING THE CASE THEY NEEDED TO CUT A ROD. WE USED THE NEW TRIALTIS ROD CUTTER, AFTER CUTTING THE ROD THE ROD CUTTER WOULD NOT OPEN TO CUT ANOTHER ROD. AFTER THE CASE HE INSPECTED THE ROD CUTTER AND THERE APPEARED TO BE METAL ON METAL SCRAPING THAT IS NOT ALLOWING THE INSTRUMENT TO BE USED CORRECTLY. HE INSPECTED THE FINAL TIGHTENERS AND THE DISTAL END OF THE DRIVE MECHANISM SHOWED SIGNS OF STRIPPING AND THEY WERE DISCARDED FOLLOWING THE CASE. HE ALSO MENTIONED THAT THE TRIALTIS GREY TORQUE HANDLE WAS NOT PERFORMING UP TO HIS STANDARDS SET PRIOR BY OUR VERSE AND EXPEDIUM FINAL TIGHTENERS. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THEY USED ANOTHER FINAL TIGHTENER DRIVER AND HAD TO USE ANOTHER ROD C
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456260 ↗MalfunctionOct 15, 2024Break; Entrapment of Device; Break; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED STATES THAT ALL FRAGMENTS RETAINED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20451001 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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