VIPER 286710490Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705034213880), received between Apr 22, 2020 and Feb 18, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED WHEN YOU INSERT THE RACHET, IT MOVES IN THE HANDLE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376968 ↗
• MalfunctionFeb 18, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED WHEN YOU INSERT THE RACHET, IT MOVES IN THE HANDLE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376966 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE RATCHETING ADAPTOR WAS BROKEN DURING AN ANTERIOR & POSTERIOR LUMBAR FUSION. WHILE THE SCRUB NURSE WAS LOADING A PEDICLE SCREW, THE ADAPTOR SUDDENLY SNAPPED AND FELL FROM THE IMPLANT SET. THE IMPLANT SENT NEEDED TO BE REPLACED DUE TO CONTAMINATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128434 ↗
• MalfunctionNov 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  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 RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242168 ↗
• MalfunctionNov 6, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE RATCHET IS BROKEN AND THE SCREWDRIVER TURNED ROUND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073951 ↗
• MalfunctionNov 2, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE CLEANING PROCESS IT WAS MENTIONED THAT THE RATCHET IS BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058281 ↗
• MalfunctionOct 26, 2023Misassembled; Misassembled

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE RATCHETING PIECES ARRIVED DISASSEMBLED AND BADLY COUPLED. FINAL TIGHTENER: THE RECESSES OF THE SCREWDRIVER ARE OVERSIZED TO THE INTERNAL SCREW, SO THEY DID NOT FIT ENOUGH TO MAKE THE FINAL ADJUSTMENT. THE SYSTEM WAS CLOSED WITHOUT THE USE OF THE TORQUE. THE 3 PIECES ARE MARKED WITH A RED TAPE ON THE EQUIPMENT FOR RETURN. THE SURGERY WAS FINISHED WITHOUT INCONVENIENCES OR AFFECTATION TO THE PATIENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012071 ↗
• MalfunctionOct 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS. IT WAS REPORTED THAT DURING THE CLEANING PROCESS IT WAS MENTIONED THAT THE SCREWDRIVERS NO LONGER FIX THE SCREWS, RATCHET BROKEN. NO PATIENT HARM. NO SURGERY DELAY. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916276 ↗
• MalfunctionOct 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE RATCHET WAS BROKEN.NO PATIENT INVOLVEMENTTHIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATEDTHIS IS REPORT 1 OF 1 FOR COMPLAINT PC-001439250

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860975 ↗
• MalfunctionJul 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING REPROCESSING THE RATCHES FRACTURED INTO TWO OR MORE PIECES. DURING REPROCESSING THE SCREWDRIVER´S TIP TWISTED. SO SURGICAL DELAY, NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392619 ↗
• MalfunctionJul 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING REPROCESSING THE RATCHES FRACTURED INTO TWO OR MORE PIECES. DURING REPROCESSING THE SCREWDRIVER´S TIP TWISTED. SO SURGICAL DELAY, NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392585 ↗
• MalfunctionJul 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS ON (B)(6) 2023, IT WAS MENTIONED THAT THE RATCHET WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333390 ↗
• MalfunctionApr 28, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: BOTH RATCHET ADAPTERS HAVE BEEN REPORTED AS DEFECTIVE. ONE OF THE TWO IS BROKEN IN THE MIDDLE. IN THE SECOND CASE, THE RATCHET DOES NOT WORK ANYMORE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833383 ↗
• MalfunctionFeb 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, BOTH RATCHET ADAPTERS HAVE BEEN REPORTED AS DEFECTIVE. ONE OF THE TWO IS BROKEN IN THE MIDDLE AND IN THE SECOND CASE, THE RATCHET DOES NOT WORK ANYMORE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419083 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT WAS USED PRE OPERATIVELY TO PRACTICE LOADING A SCREW. THE INSTRUMENT IS NOT RATCHETING AND WAS REMOVED FROM SET UP PRE-OP. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375810 ↗
• MalfunctionJan 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE CUSTOMER COMPLAINED THAT DURING CLEANING THE INSTRUMENT FRACTURED. THERE WAS NO PATIENT INVOLVED AND NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186122 ↗
• MalfunctionNov 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE POLY DRIVER - THE DRIVE TURNED OFF - THE RATCHET ADAPTER BROKE OFF. THE EVENT OCCURRED INTRA-OP WITHOUT TIMELY DELAY DUE TO USE OF A SUBSTITUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM 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 15775787 ↗
• MalfunctionOct 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEM WAS FRAGMENTED BY USE. THERE WAS NO PATIENT HARM, AND NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THIS REPORT INVOLVES ONE VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679423 ↗
• MalfunctionOct 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEM WAS FRAGMENTED BY USE. THERE WAS NO PATIENT HARM, AND NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM RATCHETING ADAPTER, CANN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679420 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING CLEANING PROCESS IT WAS RECOGNIZED THAT THE RATCHET BROKEN, SC SCREWDRIVER TIP TURNED OFF NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473317 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT DURING CLEANING PROCESS IT WAS RECOGNIZED THAT THE RATCHET BROKEN, SC SCREWDRIVER TIP TURNED OFF NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15472810 ↗
• MalfunctionJul 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO TWO OR MORE PARTS. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1)RATCHETING ADAPTER, CANNULATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914164 ↗
• MalfunctionMay 9, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE RATCHET IS BROKEN. THERE WAS NO PATIENT AND SURGERY IMPACT. THIS REPORT IS FOR ONE (1) RATCHETING ADAPTER, CANNULATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338344 ↗
• MalfunctionMay 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN INSPECTION IT WAS NOTICED THAT THE RATCHET MECHANISM OF THE RATCHET IS BROKEN AND THE TIP OF THE VIPER HAS BEEN STRIPPED. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS IS FOR A RATCHET ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315989 ↗
• MalfunctionSep 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY THE INSTRUMENT FRACTURED. THERE WAS NO PART REMAINING IN PATIENT, NO PATIENT HARM, NO SURGICAL DELAY REPORTED. ANOTHER INSTRUMENT WAS AVAILABLE, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES. THIS REPORT IS FOR A RATCHETING ADAPTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421988 ↗