VIPER 286745500Recalls & reported problems
Depuy Spine, LLC · VIPER 2 SYSTEM FINAL TIGHTENER HANDLE, TORQUE LIMITING · Class 1
Quick summary
This DePuy Spine VIPER 2 torque tightening handle has 94 reports, including 1 injury and no deaths. Common reports describe the handle failing calibration or torque checks, such as during annual testing by a distributor, and some describe it breaking during tightening. Reports rose from 2 in the prior 12 months to 20 in the latest 12 months. 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
- 94
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10705034214863), received between Aug 16, 2017 and Jun 26, 2026 — classified as 1 injury, 93 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (62 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.
Reports received per month
Most reported problems
Device problems
- Calibration Problem62
- Mechanical Problem15
- Device-Device Incompatibility8
- Break5
- Material Twisted/Bent4
- Contamination /Decontamination Problem2
- Material Integrity Problem2
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient15
- No Patient Involvement7
- Insufficient Information4
- Foreign Body In Patient1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Break
IT WAS REPORTED THE TORQUE WRENCH BROKE WHEN WE TRIED TO APPLY THE FINAL TIGHTENING. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637797 ↗MalfunctionFeb 18, 2026Calibration Problem
IT WAS REPORTED THE TORQUE TESTING FAILED. NO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376230 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336399 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336392 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335475 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335454 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335448 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335444 ↗MalfunctionFeb 13, 2026Calibration Problem
IT WAS REPORTED THAT DURING ANNUAL TORQUE TESTING BY THE DISTRIBUTOR, SEVERAL DEVICES FAILED. THERE WERE NO RELATED PROCEDURES, AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24335440 ↗MalfunctionDec 9, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759691 ↗MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727144 ↗MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23727135 ↗MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23726811 ↗MalfunctionDec 5, 2025Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent
IT WAS REPORTED THE DEVICES ARE WORN. IT WAS REPORTED THE DEVICES ARE WORN. TORQUE NOT SUFFICIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23726761 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715044 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715000 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714908 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714881 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714849 ↗MalfunctionDec 4, 2025Calibration Problem; Calibration Problem
ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714794 ↗MalfunctionSep 15, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FINAL TIGHTENER TORQUE HANDLE WAS TOO HARD TO TORQUE DURING A SPINAL FUSION SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AS A REPLACEMENT WAS PROVIDED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050249 ↗MalfunctionMar 6, 2025Calibration Problem; Calibration Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE SURGEON ATTEMPTED TORQUE-OUT, BUT TORQUE-OUT WAS IMPOSSIBLE EVEN THOUGH THE TORQUE REACHED TO THE REQUIRED VALUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. NO ADDITIONAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536352 ↗MalfunctionOct 9, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE MALFUNCTION WAS DISCOVERED IN (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 20410003 ↗MalfunctionSep 23, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT PATIENT UNDERWENT A FUSION SURGERY (T11-L2) ON (B)(6) 2024. DURING THE FINAL FASTENING OF THE T12 SET SCREW, THE TIP OF THE SCREWDRIVER SHAFT BROKE OFF AND WAS STUCK IN THE SET SCREW AND COULD NOT BE REMOVED. THE OTHER SET SCREWS WERE FINAL FASTENED USING ANOTHER TORQUE HANDLE AND SCREWDRIVER, AND SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON MENTIONED THAT THE FINAL FASTENING TORQUE WAS NOT EASY TO APPLY AND THAT THE TIP OF THE SCREWDRIVER SHAFT BROKE OFF WHEN HE TIGHTENED IT WITH A LOT OF FORCE. HE ALSO THOUGHT THAT THE SETSCREW WOULD NOT COME LOOSE BECAUSE HE HAD TIGHTENED IT CONSIDERABLY. THEREFORE, FOLLOW-UP OBSERVATION IS PLANNED. THIS REPORT IS FOR A VIPER2 FINAL TIGHTENER HANDLE.
Patient problems: Foreign Body In Patient
MAUDE report 20283958 ↗MalfunctionSep 23, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED THAT THE VIPER2 FINAL TIGHTENER HANDLE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. ALL INFORMATION HAS BEEN RECEIVED AND NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280788 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.