VIPER 286715300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034214023), received between Feb 13, 2020 and Apr 20, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, WHILE IN FORWARD POSITION THE HANDLE SLIPS. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926365 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE RATCHETING PORTION WAS BROKEN ON THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364244 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE RATCHETING PORTION WAS BROKEN ON THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364243 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE RATCHETING PORTION WAS BROKEN ON THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364242 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE RATCHETING PORTION WAS BROKEN ON THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364241 ↗
• MalfunctionDec 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824515 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED ON JUNE 5, 2024, SALES REPRESENTATIVE RECEIVED SET BACK FROM STERILE PROCESSING (SPD) AND THE DRIVER HANDLE WAS IN PIECES. IT CAME APART WHILE BEING CLEANED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE VIPER2 RATCHTING MODULAR STRAI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655685 ↗
• MalfunctionFeb 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024. THAT THE CUSTOMER RECEIVED A DIRTY ITEM IN AN ORTHOKIT LOANER SET: ACCORDING TO THE PICTURES, THERE IS CONSIDERABLE SOILING ON THE HANDLE (DARK PARTICLES ON A BLUE BACKGROUND). NO PATIENT INVOLVEMENT. THERE WAS NO SURGERY DELAY.  IT IS NOTICED IN THE STERILIZATION AREA BEFORE OP- AFTER DELIVERY. THIS REPORT IS FOR ONE (1) VIPER2 RATCHTING MODULAR STRAI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806641 ↗
• MalfunctionAug 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 14-AUGUST-2023, THE BUTTON ON THE HANDLE IN QUESTION COULD NOT BE PRESSED WHEN IT WAS ATTEMPTED TO ATTACH A SHAFT. THE ISSUE WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR, THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM STRAIGHT HANDLE, CANNULATED AND RATCHETING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632872 ↗
• MalfunctionNov 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE HANDLE IN QUESTION WAS USED IN AN UNKNOWN SURGERY ON (B)(6) 2022. ON (B)(6) 2022, IT WAS FOUND THAT THE BUTTON PART OF THE HANDLE HAD BEEN DISASSEMBLED DURING CLEANSING AFTER THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM STRAIGHT HANDLE, CANNULATED AND RATCHETING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735293 ↗
• MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION. THE SCRUB NURSE PREOPERATIVELY TRIED TO CONNECT THE HEAD ADJUSTER TO A TEARDROP HANDLE (279702120), WHICH FAILED. ALSO, TRIED TO CONNECT THE HEAD ADJUSTER WITH ANOTHER COUNTERPART HANDLES SUCH AS 279702140, 286715300, AND 299704135, WHICH ALL WAS FAILED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER2 RATCHETING MODULAR STRAI. THIS REPORT IS 4 OF 5 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756026 ↗
• MalfunctionFeb 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SCREW SLIPPED OFF PEDICLE AND WAS INSERTED INTO L4/5 DISC SPACE. BRAINLAB JAM SHIIDI AND 1.45MM GUIDEWIRE WERE ALSO USED. THE V2 RATCHETING T HANDLE WAS UNABLE TO BE REMOVED AFTER THE PROCEDURE. SURGICAL DELAY OF THIRTY MINUTES WAS REPORTED. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT RATCHETING HANDLE, CANNULATED. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706249 ↗