VIPER 286720000Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705034214177), received between Aug 16, 2017 and Mar 24, 2025 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW HEAD WAS BROKEN OFF INTRA-OPERATIVELY. THE TIP OF THE SCREWDRIVER WAS UNSTABLE AND BROKE. THE BROKEN FRAGMENT REMAINED IN THE HEAD OF THE SCREW. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. A NEW SCREW WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675965 ↗
• MalfunctionAug 30, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER WAS BROKEN. THE PRODUCT WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION REQUIRED AND AN UNKNOWN DELAY AND NO IMPACT TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20109174 ↗
• MalfunctionAug 30, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER WAS BROKEN. THE PRODUCT WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION REQUIRED AND AN UNKNOWN DELAY AND NO IMPACT TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20109164 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER BROKE. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19259290 ↗
• MalfunctionApr 25, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  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 POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 2 OF 7 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181770 ↗
• MalfunctionDec 28, 2023Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INSPECTION/REPROCESSING, THE THREADING AT THE TIP OF THE INSTRUMENT IN QUESTION WAS FOUND TO BE WORN AND TORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409623 ↗
• MalfunctionNov 30, 2023Break; Break

  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 SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 2 OF 3 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240667 ↗
• MalfunctionJul 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS ON UNKNOWN DATE IN (B)(6) 2023, IT WAS NOTED THAT THE SCREWDRIVER TIP WAS BROKEN OFF AND THE TORQUE SHAFT WAS TURNED ROUND. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267185 ↗
• MalfunctionMay 17, 2023Break; Break

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945775 ↗
• MalfunctionApr 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS ON AN UNKNOWN DAY IN (B)(6) 2023, IT WAS MENTIONED THAT THE SCREWDRIVER TIP WAS BROKEN OFF. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790834 ↗
• MalfunctionMar 7, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CLEANING PROCESS THE CSSD MANAGER NOTICED THAT THE SCREWDRIVER TIP WAS DEFECTIVE AND THAT THE TROCAR DOES NOT HOLD THE SLEEVE TIGHTLY. NO PATIENT IMPACT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495066 ↗
• MalfunctionFeb 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT THE WRENCH ARRIVED BROKEN IN THE TIP. ( REFª 286720000). THE WRENCH ARRIVED CRUSHED IN THE TIP ( REFª 286745550). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452993 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690242 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690190 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690176 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690154 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON OCTOBER 6, 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690153 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690150 ↗
• MalfunctionOct 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON INSPECTION OF KITS IN CPD DECONTAMINATION, IT WAS DISCOVERED THAT THE VERY TIP OF THE VIPER THREADED DRIVERS WERE BROKEN OFF. THIS PARTICULAR BROKEN TIP WAS EXTREMELY HARD TO SEE WITHOUT THE TRAINED EYE VIEWING THE INSTRUMENT. OTHER KITS WERE THEN INSPECTED, AND THE BROKEN TIP THREADED DRIVERS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690149 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO DRIVERS BROKE IN THE MIDDLE OF THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330076 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO DRIVERS BROKE IN THE MIDDLE OF THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330072 ↗
• MalfunctionApr 18, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR PC- (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING THAT DURING THE CLEANING PROCESS, IT WAS OBSERVED THAT THE TIP ON THE IMPLANT DRIVER DEVICE WAS STRIPPED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE POLY SCW DRIVER SHFT, CANNULTD DEVICE. THIS COMPLAINT INVOLVES TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137760 ↗
• MalfunctionApr 18, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING THAT DURING THE CLEANING PROCESS, IT WAS OBSERVED THAT THE TIP ON THE IMPLANT DRIVER DEVICE WAS STRIPPED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137758 ↗
• MalfunctionMar 25, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE CUSTOMER REPORTS THAT THE TIP OF THE SCREWDRIVER HAS BEEN STRIPPED AND A PROPER PICK UP OF SCREWS IS NOT POSSIBLE ANYMORE. NO PATIENT OR SURGERY IMPACT. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908246 ↗
• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN ANTERIOR/POSTERIOR LUMBAR FUSION PROCEDURE ONE (1) VIPER UNIVERSAL POLY DRIVER WAS BROKEN, AND TWO (2) T20 DRIVER SHAFTS WERE STRIPPED. THE SURGEON WAS PLACING UNKNOWN SCREWS IN THE PATIENT WHEN TWO (2) POLY SCREWDRIVER SHAFTS TIPS BROKE OFF. HE THEN ATTEMPTED TO USE THE VIPER2 T20 HEXLOBE DRIVER AND T20 SCREWDRIVER SHAFT WHICH BOTH STRIPPED. HE ADVANCED USING THE VIPER UNIVERSAL POLY DRIVER AND THE TIP OF THE DRIVER WAS FOUND TO BE BROKEN ON THE BACK TABLE AFTER IT WAS TAKEN OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666133 ↗