TRIALTIS 5161-00-5069Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034589282), received between Aug 15, 2024 and Jun 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVER TIP WAS STRIPPED WHEN ASSEMBLING TRAYS AFTER A SURGERY. NO COMPLAINTS WERE MADE DURING THE CASE AND PATIENT WAS NOT AFFECTED IN ANY WAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214126 ↗
• MalfunctionJun 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE, WHILE THE INSERTING AN 8.0MM ILIAC SCREW, THE OUTER SLEEVE WAS ACCIDENTALLY DEPRESSED AND DISENGAGED FROM THE SCREW HEAD. THE NAVIGATED SCREWDRIVER THEN STRIPPED AT THE TEETH OF THE INSTRUMENT. SURGERY WAS NOT DELAYED AND WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. THE ITEM WAS REMOVED FROM USE. THE SCREW WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124350 ↗
• MalfunctionJan 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ATRIALIS NAV DRIVER WAS STRIPPED. A REPLACEMENT IS REQUIRED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272536 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER BROKE WHEN ATTEMPTING TO INSERT A SCREW FURTHER DURING A SPINE PROCEDURE. A 10X90MM SCREW WAS INSERTED. SURGEON ATTEMPTED TO GO BACK WITH SCREWDRIVER TO INSERT SCREW FURTHER, AND THE TIP BROKE. THE TIP WAS REMOVED FROM SCREW. THERE WAS A SURGICAL DELAY OF 2 MINUTES. FRAGMENT WAS GENERATED AND WAS EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046730 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE T27 DRIVER SHAFT TIP BROKE OFF WHILE INSERTING A 9.0MM X 55MM SCREW IN THE PELVIS. THIS WAS A REVISION OF A PREVIOUSLY PLACED CONSTRUCT. A 8.0MM X 55MM SCREW WAS REMOVED AND THE TRIALTIS 9.0MM X 55MM SCREW WAS INSERTED IN THE SAME TRAJECTORY. WHEN THE SCREW WAS IN 75% OF THE WAY, THE TIP OF THE DRIVER SHAFT BROKE OFF. THE SCREW WAS LEFT IN AT THIS POINT AND THE CONSTRUCT WAS COMPLETED WITHOUT ANY ADDITIONAL INCIDENTS. THERE WAS SURGICAL DELAY OF 5 MINS. THE SCREW WAS LEFT PROUD AND ATTACHED A CONNECTOR TO COMPLETE THE CONSTRUCT. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES OCCURRED. THIS REPORT IS FOR ONE (1) SCREWDRIVER, T27 NAV CANN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996325 ↗