VIPER 286715350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034214030), received between Apr 27, 2021 and Oct 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A REMOVAL PROCEDURE IN THE LUMBAR SPINE FOR TREATING OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL) ON (B)(6) 2021. DURING THE PROCEDURE, THE TIP OF THE T20 SCREWDRIVER WAS STRIPPED, THE TIP OF THE XPDM POLY SCREWDRIVER CHIPPED AND THE VIPER2 RATCHET HANDLE BROKE. IT WAS CONFIRMED THAT NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING REPLACEMENT INSTRUMENTS. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 RATCHETING MODULAR THAN. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656650 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE RATCHETING MECHANISM WAS NOT WORKING PROPERLY. THE HANDLE WAS BROKEN AND IT WAS PASSED OFF THE FIELD. THE HANDLE WAS REMOVED FROM THE STERILE FIELD AND TAGGED AS BROKEN. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM T-HANDLE, RATCHETING AND CANNULATED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733443 ↗