VIPER 286735750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034214689), received between Sep 29, 2022 and Oct 4, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 16 2023, THE SCREWDRIVER T20 DID NOT TAKE THE SCREWS OF THE SYSTEM VIPER2 PROPERLY. WHEN MAKING THE REDUCTION AND POSITIONING THE REDUCTION SLEEVES, THEY DO NOT SLIDE EASILY. THERE WAS NO INVOLVEMENT IN THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) REDUCTION CAP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869215 ↗
• MalfunctionOct 21, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING VIPER 2 TRAUMA FIXATION, THE COLLARS ON THE VIPER 2 REDUCTION CAPS WERE LOOSE AND NOT SECURING TO THE SCREW EXTENSIONS MAKING REDUCTION TRICKIER FOR SURGEONS TO PERFORM AND ADDING TO THE PROCEDURE TIME. IT¿S ALSO MAKING THE SURGEON TO QUESTION WHETHER THEY ARE GETTING ENOUGH REDUCTION WITH THE CAPS BEING LOOSE. THERE WAS SURGICAL DELAY OF APPROXIMATE TEN (10) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SAFELY AND THERE WAS NO PATIENT IMPACT. THERE WAS NO FURTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) REDUCTION CAP. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651258 ↗
• MalfunctionOct 21, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING VIPER 2 TRAUMA FIXATION, THE COLLARS ON THE VIPER 2 REDUCTION CAPS WERE LOOSE AND NOT SECURING TO THE SCREW EXTENSIONS MAKING REDUCTION TRICKIER FOR SURGEONS TO PERFORM AND ADDING TO THE PROCEDURE TIME. IT¿S ALSO MAKING THE SURGEON TO QUESTION WHETHER THEY ARE GETTING ENOUGH REDUCTION WITH THE CAPS BEING LOOSE. THERE WAS SURGICAL DELAY OF APPROXIMATE TEN (10) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SAFELY AND THERE WAS NO PATIENT IMPACT. THERE WAS NO FURTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) REDUCTION CAP. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651256 ↗
• MalfunctionOct 21, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING VIPER 2 TRAUMA FIXATION, THE COLLARS ON THE VIPER 2 REDUCTION CAPS WERE LOOSE AND NOT SECURING TO THE SCREW EXTENSIONS MAKING REDUCTION TRICKIER FOR SURGEONS TO PERFORM AND ADDING TO THE PROCEDURE TIME. IT¿S ALSO MAKING THE SURGEON TO QUESTION WHETHER THEY ARE GETTING ENOUGH REDUCTION WITH THE CAPS BEING LOOSE. THERE WAS SURGICAL DELAY OF APPROXIMATE TEN (10) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SAFELY AND THERE WAS NO PATIENT IMPACT. THERE WAS NO FURTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) REDUCTION CAP. THIS IS REPORT 4 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651239 ↗
• MalfunctionSep 29, 2022Device Slipped; Device Slipped

  IT WAS FURTHER REPORTED THAT NO OTHER MEDICAL INTERVENTION REQUIRED. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505923 ↗