VIPER 286735400Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10705034214580), received between Oct 27, 2014 and Dec 5, 2025 — classified as 5 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Break” (73 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 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION (L5) FOR SPINAL STENOSIS ON (B)(6) 2025. THE EXTENDED FUSION (L3) WAS PERFORMED AT REOPERATION OF THE FIXATION (L4/5). THE INSERTER WAS USED TO REMOVE THE L5 SET SCREW, BUT THE TIP WAS TWISTED OFF. THE TIP WAS THEN REMOVED AND DISCARDED BY THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728608 ↗
• MalfunctionJun 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION PERFORMED ON (B)(6) 2025. DURING SURGERY, AFTER INSERTING THE SET SCREW WITH THE SET SCREW INSERTER, THE SURGEON FASTENED IT SO HARD THAT THE TIP OF THE SET SCREW INSERTER BROKE. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320279 ↗
• MalfunctionMay 17, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION ON (B)(6) 2025. DURING SURGERY, AFTER INSERTING THE SET SCREW WITH THE INSERTER, THE SURGEON FASTENED IT SO HARD THAT THE TIP OF THE INSERTER BROKE. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT STATUS IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041098 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20431802 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE KEY ARRIVED WITH THE BROKEN TIP. A SECOND KEY WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20039614 ↗
• MalfunctionMay 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  I WAS REPORTED THAT UPON SETTING UP FOR SURGERY, IT WAS DETERMINED THAT THE TIP OF THE CAP INSERTER WAS BENT AND UNABLE TO PICK UP THE LOCKING CAP THAT IT'S DESIGNED TO WORK WITH. THERE WAS NO PATIENT CONSEQUENCES OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VIPER2 X25 SET SCREW INSERTER, THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397706 ↗
• MalfunctionMay 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TOOLS QUICKLY LOST THEIR UTILITY FEATURES. THEY WERE DEFORMED AND COULD NOT BE USED CORRECTLY AND SAFELY WITHOUT DELAY IN THE PROCEDURES. TO PROCEDURE COMPLETE THE PHYSICIAN USED ANOTHER PRODUCT, THE SAME TYPE. THE PATIENT WAS REPORTED AS GOOD. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332965 ↗
• MalfunctionMay 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TOOLS QUICKLY LOST THEIR UTILITY FEATURES. THEY WERE DEFORMED AND COULD NOT BE USED CORRECTLY AND SAFELY WITHOUT DELAY IN THE PROCEDURES. TO PROCEDURE COMPLETE THE PHYSICIAN USED ANOTHER PRODUCT, THE SAME TYPE. THE PATIENT WAS REPORTED AS GOOD. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332953 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT ON APRIL 4, 2024, A SALES CONSULTANT RECEIVED CONCERNS OVER THE QUALITY OF BASIC TOOLS IN THE VIPER2 SERIES (SCREWDRIVERS AND FINAL TIGHTENING WRENCH) AND EXPEDITION 5.5 (FINAL TIGHTENING SCREWDRIVER). COMPARED TO PREVIOUS YEARS, THE TOOLS UNDERGO RAPID LIFE, EVEN AFTER A FEW TREATMENTS. CUSTOMERS SUGGEST THE SCREWDRIVERS ARE MORE PLASTIC, THEY DEFORM, PREVENTING PROPER USE. THESE OBSERVATIONS WERE MADE BY THE SURGEON(S) INTRAOPERATIVELY. THE DEVICES WERE SWITCHED FOR NEW ONES. THIS REPORT IS FOR A VIPER2 X25 SET SCREW INSERTER. THIS IS REPORT 7 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182007 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, A SALES CONSULTANT RECEIVED CONCERNS OVER THE QUALITY OF BASIC TOOLS IN THE VIPER2 SERIES (SCREWDRIVERS AND FINAL TIGHTENING WRENCH) AND EXPEDITION 5.5 (FINAL TIGHTENING SCREWDRIVER). COMPARED TO PREVIOUS YEARS, THE TOOLS UNDERGO RAPID LIFE, EVEN AFTER A FEW TREATMENTS. CUSTOMERS SUGGEST THE SCREWDRIVERS ARE MORE PLASTIC, THEY DEFORM, PREVENTING PROPER USE. THESE OBSERVATIONS WERE MADE BY THE SURGEON(S) INTRAOPERATIVELY. THE DEVICES WERE SWITCHED FOR NEW ONES. THIS REPORT IS FOR A VIPER2 X25 SET SCREW INSERTER. THIS IS REPORT 3 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181877 ↗
• MalfunctionMar 18, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS PLIF (L4) PERFORMED ON (B)(6) 2024. IN THE SURGERY, WHEN FASTENING THE SET SCREW, THE TIP OF THE INSERTER IN QUESTION WAS BROKEN WITH A CRACKING SOUND. THE DEBRIS WAS REMOVED BY FORCEPS AND NO PIECES WERE LEFT IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE VIPER2 X25 SET SCREW INSERTER, THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18921638 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 10 2024, THE INNER SHAFT COULD NO LONGER BE SCREWED IN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR ONE (1) VIPER2 X25 SET SCREW INSERTER, THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581347 ↗
• MalfunctionNov 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING THE CLEANING PROCESS VARIOUS ISSUES WERE DISCOVERED. THE RATCHET IN QUESTION NO LONGER HOLDS ITS SETTINGS, THE POLYAXIAL SCREWDRIVER WAS FOUND WITH A PIECE BROKEN OFF, AND IT IS NO LONGER POSSIBLE TO MOUNT INNIES TO THE INNIE INSERTER. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242083 ↗
• MalfunctionNov 6, 2023Break; Break

  THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: Insufficient Information

  MAUDE report 18076017 ↗
• MalfunctionOct 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE SCREWDRIVER TIP WAS UNSCREWED AND THE ROD HOLDER TIP WAS BROKEN OFF. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912514 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878511 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878510 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878509 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878507 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878506 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878504 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON 07-SEPTEMBER-2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878500 ↗
• MalfunctionOct 5, 2023Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  MM 10.5.23 DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS IN QUESTION CANNOT BE CLEANED AND DISINFECTED IN ACCORDANCE WITH THE MIFU. ON (B)(6) 2023 WHILE INSPECTING THE INSTRUMENTS WITH A BORESCOPE IN MDRD, IT WAS FOUND THAT THE CANNULATION IN THE PRODUCT TRANSITIONS FROM NARROW TO WIDE TO NARROW AGAIN, CREATING DIFFICULTIES WITH MANUAL CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING. THIS IS REPORT 2 OF 8 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878499 ↗
• MalfunctionAug 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF PERFORMED ON (B)(4), 2023. AFTER INSERTING 4 X-TAB SCREWS, THE SURGEON INSTALLED SET SCREWS. A SNAPPING SOUND WAS HEARD WHEN THE SURGEON WAS TIGHTENING THE 4TH SET SCREW. THE INSERTER WAS TAKEN OUT AND FOUND THAT THE TIP OF IT WAS BROKEN OFF. THE BROKEN FRAGMENT WAS REMOVED WITH FORCEPS. THE SURGEON CONFIRMED THAT THERE WAS NO BROKEN FRAGMENT LEFT IN THE PATIENT¿S BODY. AFTER THAT, THE PROCEDURES WERE PROCEEDED AS USUAL, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER2 X25 SET SCREW INSERTER, THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572896 ↗
• MalfunctionJun 2, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF PERFORMED ON (B)(6) 2023. THE TIP OF THE SET SCREW INSERTER BROKE WHEN IT WAS USED TO TIGHTEN A SET SCREW. BROKEN FRAGMENTS OF THE SET SCREW INSERTER WERE REMOVED AND THERE WAS NO IMPACT ON THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VIPER2 X25 SET SCREW INSERTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17053318 ↗