VIPER 279734000Recalls & reported problems

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 10705034200279), received between Aug 4, 2017 and Apr 8, 2026 — classified as 16 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Break” (171 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 241 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A SCREW WOULDN´T COME LOOSE FROM THE SCREWDRIVER, RESULTING IN THE NEED TO USE A NEW SCREW AND SCREWDRIVER. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819421 ↗
• MalfunctionApr 6, 2026Break; Material Twisted/Bent

  TIP OF THE SCREW DRIVER IS COMPLETELY WITHOUT THREAD TO ENGAGE IN THE NOTCH OF THE SCREW. NOT SURE IF THE TIP IS BROKEN OFF OR WORN OUT AND AWAY. NO CONSEQUENCE FOR PATIENT. SURGERY WAS PERFORMED AS PLANNED; THERE WAS NO DELAY. ANOTHER INSTRUMENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793944 ↗
• InjuryDec 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE WHEN INSERTING THE SCREW. IT BECAME ONE WITH THE SCREW CORE, MAKING IT DIFFICULT TO REMOVE. THE SURGEON DETERMINED THAT THERE WAS NO PROBLEM WITH INSERTING THE ROD, AND SO THE TIP OF THE SCREWDRIVER SCREW WAS LEFT IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23817914 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE OFF DURING SURGERY. THERE WAS NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. SURGEON USED A NEW SCREWDRIVER AND THE PROCEDURE FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378934 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2025. THE TIP OF THE SCREWDRIVER BROKE OFF WHILE TURNING THE SCREW AND GOT STUCK IN THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351787 ↗
• MalfunctionSep 11, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN OPERATION, THE TIP OF THE VIPER SCREWDRIVER HAS BROKEN OFF AND REMAINED IN THE SCREW HEAD. IT WAS NOT POSSIBLE TO GET THE PIECE OUT, IN THE SCREW IS, AS IN ALL OTHERS, ROD AND INNIE IN IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23032022 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543057 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW DRIVER BROKE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543009 ↗
• MalfunctionJun 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF WHEN INSERTING THE SCREW DURING A SPINAL FUSION. FRAGMENT WAS RETAINED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH NO DELAY AND NO PATIENT CONSEQUENCE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22356331 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE SCREWDRIVER BROKE WHOLE PUTTING IN THE SCREW. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114213 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT WHILE PLACING THE SPINE SCREW IN THE PEDICLE DURING AN A & P LUMBAR FUSION, THE SCREWDRIVER BROKE INSIDE THE SCREW IN THE MIDDLE OF THE TRAJECTORY. IT WAS NECESSARY TO PLACE A ROD IN THE SCREW, WITH A SINGLE INNER SET SCREW TO LOCK IT. THIS WAY, THE SCREW WAS MONOAXIAL. AFTER THIS, ROTATION OF THE ROD WAS DONE TO TAKE OUT THE SCREW. SURGERY WAS DELAYED BY 30 MINUTES DUE TO THE EVENT AND WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. NO ADDITIONAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884572 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW DRIVERS BROKE IN THE FRONT WHILE PUTTING THE SCREWS IN AND COULD NOT BE USED ANYMORE. SCREWDRIVERS WERE CHANGED TO ANOTHER SCREWDRIVERS. THERE WAS A 20 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306071 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW DRIVERS BROKE IN THE FRONT WHILE PUTTING THE SCREWS IN AND COULD NOT BE USED ANYMORE. SCREWDRIVERS WERE CHANGED TO ANOTHER SCREWDRIVERS. THERE WAS A 20 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306033 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (L5) FOR LUMBAR SPONDYLOLISTHESIS ON (B)(6) 2024. THE TIP OF THE UNIVERSAL POLY DRIVER BROKE OFF DURING INSERTION OF A 7MM-45MM SCREW IN L5, LEFT. THE BROKEN FRAGMENT OF THE UNIVERSAL POLY DRIVER WAS REMAINING IN THE SCREW, BUT THE BROKEN FRAGMENT COULD NOT BE REMOVED. A SHORT ROD WAS SET TO THE SCREWHEAD, THE FINAL TIGHTENING WAS DONE, AND THE SCREW WAS REMOVED BY TURNING COUNTERCLOCKWISE. A NEW SCREW WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138423 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 5 2024, ON A PREVIOUS INSTRUMENTED PATIENT, WHERE EVEREST SCREWS WERE FIRST REMOVED. FOR THAT REASON, NAVIGATION WAS NOT USED. A SCREW IS INSERTED BUT HAD A HARD TIME BEING INSERTED - IT SUBSEQUENTLY TURNS OUT THAT THE TIP OF THE SCREWDRIVER IS BROKEN, WHICH IS WHY THE SCREWDRIVER CANNOT GRIP THE NOTCH IN THE SCREW. BUT BECAUSE FORCE HAD TO BE USED, THE NOTCH IS UNFORTUNATELY DESTROYED AND THE SCREW CANNOT BE IMMEDIATELY REMOVED (IT IS NOT SCREWED IN FAR ENOUGH). WHEN SUBSEQUENTLY TRYING TO PUT A SCREW ON ANOTHER LEVEL, THE TIP OF THE SCREWDRIVER BREAKS. VARIOUS PLIERS AND OTHER THINGS IN THE ATTEMPT TO REMOVE THE SCREWS WERE USED. SURGERY TIME PROLONGED WITH 2 HOURS DUE TO ISSUE WITH INSERTION OF SCREWS AND BROKEN SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683600 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 5 2024, ON A PREVIOUS INSTRUMENTED PATIENT, WHERE EVEREST SCREWS WERE FIRST REMOVED. FOR THAT REASON, NAVIGATION WAS NOT USED. A SCREW IS INSERTED BUT HAD A HARD TIME BEING INSERTED - IT SUBSEQUENTLY TURNS OUT THAT THE TIP OF THE SCREWDRIVER IS BROKEN, WHICH IS WHY THE SCREWDRIVER CANNOT GRIP THE NOTCH IN THE SCREW. BUT BECAUSE FORCE HAD TO BE USED, THE NOTCH IS UNFORTUNATELY DESTROYED AND THE SCREW CANNOT BE IMMEDIATELY REMOVED (IT IS NOT SCREWED IN FAR ENOUGH). WHEN SUBSEQUENTLY TRYING TO PUT A SCREW ON ANOTHER LEVEL, THE TIP OF THE SCREWDRIVER BREAKS. VARIOUS PLIERS AND OTHER THINGS IN THE ATTEMPT TO REMOVE THE SCREWS WERE USED. SURGERY TIME PROLONGED WITH 2 HOURS DUE TO ISSUE WITH INSERTION OF SCREWS AND BROKEN SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683574 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (L2-S2AI) WAS PERFORMED ON (B)(6) 2024. THIS WAS A SPINAL FUSION (L2-S2AI) FOR A PATIENT WHO HAD A LIF CAGE FROM ANOTHER COMPANY PLACED AT L2-L5 A FEW DAYS EARLIER. L2-L4: POSTERIOR FUSION WITH XTAB. L5-S1: PLIF WITH EXPEDIUM, XTAB AND PROTI TPAL S2AI: EXPEDIUM SAI SCREW. DURING SURGERY, THE SURGEON ATTEMPTED TO INSERT THE EXPEDIUM SCREW TO THE L5 VERTEBRA WITH THE SCREWDRIVER IN QUESTION, BUT THE SCREW WAS NOT STABLE. THEREFORE, THE SCREW WAS INSERTED AND REMOVED SEVERAL TIMES. HOWEVER, THE SCREW STILL DID NOT STABILIZE, SO THE SCREW WAS REMOVED. THE SURGEON CHECKED THE SCREWDRIVER IN QUESTION AND FOUND THAT THE T20-SHAPED TIP OF THE SCREWDRIVER IN QUESTION WAS MISSING. WHEN THE SURGEON CHANGED TO ANOTHER SCREWDRIVER OF THE SAME MODEL NUMBER AND WAS ABLE TO ATTACH IT TO THE SCREW AND INSERT THE SCREW WITHOUT ANY PROBLEMS. AFTER THAT, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THE SCREWDRIVER IN QUESTION WAS SHIPPED FOR THIS SURGERY AND WAS NOT USED PRIOR TO IT. ALSO, DURING THE SURGERY, WHEN THE SCREWDRIVER IN QUESTION WAS FOUND TO BE DEFECTIVE IN THE INSTALLATION OF THE FIRST SCREW, AND ONCE THE SCREW WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535382 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE VIPER SC MINIPOLY DRIVER TIP BROKE WHEN INSERTING SCREW. THE FRAGMENT WERE REMOVED AFTER. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409990 ↗
• MalfunctionSep 30, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE TIP OF THE SCREWDRIVER WAS BROKEN. FRAGMENTS WERE GENERATED AND EASILY REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN-MINUTE DELAY. PATIENT WAS OKAY. THIS REPORT IS FOR A VIPER UNIVERSAL POLY DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334909 ↗
• MalfunctionAug 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE TIP OF THE VIPER UNIVERSAL POLY DRIVER BROKE WHEN THE SURGEON WAS INSERTING THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM POLYAXIAL SCREW DRIVER T20. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20047058 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON WANTED TO PUT 9MM VIPER CFX SCREWS, HOWEVER BROKE OFF 1 VIPER CS SCREWDRIVERS. SURGEON WAS THEN ABLE TO REMOVE THE SCREW AND CUT THREADS WITH 9MM THREAD SEPARATOR. HE THEN WANTED TO INSERT THE SCREW WITH A VIPER CS SCREWDRIVER AND THEN BROKE IT OFF. HOWEVER, SINCE THE SCREW HAD TO BE INSERTED EVEN FURTHER, THE EXP SCREWDRIVER CONTINUED TO TRY AND ALSO BROKE IT OFF IN THE SCREW. THE SCREW COULD THEN NO LONGER BE INSERTED. HOWEVER, THE OP WAS SUCCESSFULLY COMPLETED. AS A RESULT, THE OPERATING ROOM HAS BEEN EXTENDED BY 2.5 HOURS. THIS REPORT IS FOR ONE (1) VIPER UNIVERSAL POLY DRIVER THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19533283 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON WANTED TO PUT 9MM VIPER CFX SCREWS, HOWEVER BROKE OFF 1 VIPER CS SCREWDRIVERS. SURGEON WAS THEN ABLE TO REMOVE THE SCREW AND CUT THREADS WITH 9MM THREAD SEPARATOR. HE THEN WANTED TO INSERT THE SCREW WITH A VIPER CS SCREWDRIVER AND THEN BROKE IT OFF. HOWEVER, SINCE THE SCREW HAD TO BE INSERTED EVEN FURTHER, THE EXP SCREWDRIVER CONTINUED TO TRY AND ALSO BROKE IT OFF IN THE SCREW. THE SCREW COULD THEN NO LONGER BE INSERTED. HOWEVER, THE OP WAS SUCCESSFULLY COMPLETED. AS A RESULT, THE OPERATING ROOM HAS BEEN EXTENDED BY 2.5 HOURS. THIS REPORT IS FOR ONE (1) VIPER UNIVERSAL POLY DRIVER THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19533282 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT ON MARCH 25, 2024 UPON PLACING A VIPER OPEN PEDICLE SCREW AT L5, THE DISTAL TIP OF THE VIPER OPEN SCREWDRIVER WAS BROKE OFF AND WAS LODGED INTO THE HEAD OF THE SCREW. SHORTLY THEREAFTER, WHILE PLACING A PEDICLE SCREW AT L4 ON THE CONTRALATERAL SIDE USING A DIFFERENT SCREWDRIVER, THE DISTAL TIP OF THAT SCREWDRIVER ALSO BROKE OFF INTO THE HEAD OF THE SCREW. THE SURGEON WAS ABLE TO LOCATE THE BROKEN TIP AT L4, WHILE THE BROKEN TIP IN THE L5 SCREW REMAINED LODGED IN THE SCREW BUT WAS SECURED DOWN BY THE ROD AND SET SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 25 MINS. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNIVERSAL POLY DRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073328 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT ON MARCH 25, 2024 UPON PLACING A VIPER OPEN PEDICLE SCREW AT L5, THE DISTAL TIP OF THE VIPER OPEN SCREWDRIVER WAS BROKE OFF AND WAS LODGED INTO THE HEAD OF THE SCREW. SHORTLY THEREAFTER, WHILE PLACING A PEDICLE SCREW AT L4 ON THE CONTRALATERAL SIDE USING A DIFFERENT SCREWDRIVER, THE DISTAL TIP OF THAT SCREWDRIVER ALSO BROKE OFF INTO THE HEAD OF THE SCREW. THE SURGEON WAS ABLE TO LOCATE THE BROKEN TIP AT L4, WHILE THE BROKEN TIP IN THE L5 SCREW REMAINED LODGED IN THE SCREW BUT WAS SECURED DOWN BY THE ROD AND SET SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 25 MINS. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNIVERSAL POLY DRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073325 ↗
• MalfunctionApr 8, 2024Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, WHEN INSERTING IN THE THIRD 6X55 MM SCREW, THE SCREWDRIVER HEAD BROKE OFF IN THE SCREW. THE FIRST TWO SCREWS COULD BE INSERTED WITHOUT ANY PROBLEMS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH APPROXIMATELY THIRTY MINUTES DELAY. PATIENT STATUS UPON DISCHARGE WAS EXCELLENT. THIS REPORT IS FOR A VIPER UNIVERSAL POLY DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060189 ↗