VIPER 286735430Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034214603), received between Apr 30, 2021 and Aug 13, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP WERE WORN DOWN AND BROKEN. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978749 ↗
• MalfunctionAug 13, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TIP WERE WORN DOWN AND BROKEN. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978285 ↗
• MalfunctionAug 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE ITEMS APPEAR TO BE WORN AND HAD BROKEN TIP. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968300 ↗
• MalfunctionAug 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE ITEMS APPEAR TO BE WORN AND HAD BROKEN TIP. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968298 ↗
• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE FINAL TIGHTENING OF THE VIPER PRIME THE SHAFT TIP BROKE OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665929 ↗
• MalfunctionApr 30, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE X25 DRIVER WAS BEING USED WITH A TORQUE HANDLE TO COMMENCE FINAL TIGHTENING OF THE SET SCREWS, WHEN THE SURGEON NOTICED THE X25 TIP WOULDN¿T ENGAGE PROPERLY. ON CLOSER INSPECTION, IT WAS NOTED THE THREADS ON THE TIP OF THE DRIVER ARE BENT. THE SURGEON USED A DIFFERENT X25 DRIVER TO COMPLETE THIS STAGE OF THE SURGERY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A VIPER2 - INT X-25, SELF-RETAIN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753199 ↗