VIPER 286745550Recalls & reported problems
Depuy Spine, LLC · VIPER 2 SYSTEM FINAL TIGHTENER DRIVER X25 · Class 1
All models of VIPER (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Viper final tightener driver is a surgical driver used to tighten set screws in a spinal implant system. Most reports describe the driver's tip being stripped or bent, and some describe it breaking during surgery, with broken pieces left in the patient. There are 258 reports, with no deaths and 6 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 263
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 10705034214870), received between Jun 23, 2017 and Sep 25, 2026 — classified as 6 injuries, 257 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (206 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent206
- Break48
- Device-Device Incompatibility15
- Entrapment of Device10
- Material Integrity Problem7
- Material Deformation5
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions195
- Insufficient Information40
- Foreign Body In Patient11
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient4
- No Code Available3
- No Patient Involvement3
- Injury1
Recent adverse event reports
The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the end off the screwdriver is stripped. There was no surgical delay or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900350 ↗MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the end off the screwdriver is stripped. There was no surgical delay or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900346 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859426 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859417 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported during the procedure the final tighter stripped which meant the final torquing of the construct could not be completed with the instrument. A second instrument in the kit was available. No patient impact and only a small 1-minute delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479015 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported that these final tighteners were missing from the set. The staff advised me they were removed as they had also stripped and were not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477088 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported that these final tighteners were missing from the set. The staff advised me they were removed as they had also stripped and were not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477060 ↗MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022477 ↗MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022475 ↗MalfunctionJun 29, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF DRIVE SHAFT WORN AND WAS NOT ENGAGING SET SCREW CORRECTLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659363 ↗MalfunctionApr 2, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE END OFF SCREWDRIVER IS STRIPPED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24768060 ↗MalfunctionApr 2, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE VIPER2 FINAL TIGHTENER DRIVER HAD ITS TIP STRIPPED IN THE SET SCREW DURING INTRA-OPERATIVE USE. THE DEVICE FAILED TO GRIP AND TORQUE FURTHER SET SCREWS, BUT AN ALTERNATIVE DRIVER WAS AVAILABLE, RESULTING IN NO DELAY TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767234 ↗MalfunctionMar 25, 2026Device-Device Incompatibility
IT WAS REPORTED THE INSTRUMENT BROKE DURING SURGERY. THE TIP WAS NOT ENGAGING WITH THE NUT. ALTERNATIVE INSTRUMENT USED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690789 ↗MalfunctionMar 16, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE FINAL TIGHTENER SCREW DRIVER SHAFT WAS STRIPPED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605784 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS A STRIPPED SCREW DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559791 ↗MalfunctionMar 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS A STRIPPED SCREW DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559789 ↗MalfunctionFeb 17, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE VIPER 2 FINAL TIGHTENERS WERE STRIPPED OUT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364211 ↗MalfunctionFeb 17, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE VIPER 2 FINAL TIGHTENERS WERE STRIPPED OUT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364209 ↗MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRIVER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923973 ↗MalfunctionDec 10, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A DRIVER WAS STRIPPED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771692 ↗MalfunctionDec 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. SETSCREW JUMPS WITH THE SHAFT WHEN SCREWING IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727691 ↗MalfunctionDec 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. SETSCREW JUMPS WITH THE SHAFT WHEN SCREWING IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727665 ↗MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. SETSCREW JUMPS WITH THE SHAFT WHEN SCREWING IN. WHEN THE INNER SET SCREW IS FINALLY TIGHTENED, YOU CAN SEE MACROSCOPICALLY THAT THE TULIP OF THE SCREW IS SLIPPING APART AND BREAK THE TOP COIL OUT OF THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727589 ↗MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. SETSCREW JUMPS WITH THE SHAFT WHEN SCREWING IN. WHEN THE INNER SET SCREW IS FINALLY TIGHTENED, YOU CAN SEE MACROSCOPICALLY THAT THE TULIP OF THE SCREW IS SLIPPING APART AND BREAK THE TOP COIL OUT OF THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727502 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE VIPER2 FINAL TIGHTENER DRIVER STRIPPED ON FINAL TIGHTENER. NO SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23705981 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
- INHANCE 6205-10-105Depuy (Ireland) · DRIVER, PROSTHESIS191 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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