VIPER 286735725Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034303499), received between Oct 13, 2020 and Nov 12, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE NUT CANNOT BE REMOVED FROM THE TOOL. NEW NUTS AND TOOLS WERE USED. NO CONSEQUENCES FOR THE PATIENT REPORTED. THERE WAS A DELAY LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666157 ↗
• MalfunctionNov 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT AN UNKNOWN SET SCREW IS STUCK INSIDE THE REDUCTION SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621980 ↗
• MalfunctionJun 23, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN NORWAY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE REDUCTION SHAFT DEVICE NO LONGER ABLE TO ENGAGE AND DEFORMED OR OTHERWISE DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14790582 ↗
• MalfunctionMay 23, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE REDUCTION SHAFT DEVICE NO LONGER ABLE TO ENGAGE AND DEFORMED OR OTHERWISE DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471563 ↗
• MalfunctionJan 31, 2022Device-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 INNIE COULD NOT BE CONNECTED TO THE INSERTER. NO SURGICAL IMPACT AND NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM REDUCTION DRIVER SHAFT 5.5 X25 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392093 ↗
• MalfunctionSep 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, THE REDUCTION SHAFT TIP WAS STUCK ON A SET SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER REDUCTION SHAFT. THERE WAS NO PATIENT OR SURGICAL IMPACT. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475418 ↗
• MalfunctionJul 29, 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, DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS DEFECTIVE DURING USE. DETACHING THE INSTRUMENT FROM THE IMPLANT WAS ONLY POSSIBLE WITH A LOT OF POWER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM REDUCTION DRIVER SHAFT 5.5 X25. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246123 ↗
• MalfunctionMar 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE CLEANING PROCEDURE IT WAS NOTICED THAT REDUCTION THREADED POST DID NOT SNAP INTO PLACE WHEN PLACED OVER REDUCTION SHAFT. THERE WAS NO SURGERY OR PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM REDUCTION DRIVER SHAFT 5.5 X25. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11415137 ↗
• MalfunctionOct 13, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS OPERATING ON A PATIENT WITH VERY DENSE SCLEROTIC BONE. THIS WAS AN INDEX SURGERY. PROPER TECHNIQUE WAS FOLLOWED BUT THE TORQUE REQUIRED TO INSERT AND ADJUST SCREWS WAS INCREDIBLY HIGH. DURING SCREW INSERTION AND ADJUSTMENT, SEVERAL SCREW DRIVERS WERE DAMAGED. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) REDUCTION SHAFT THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10672365 ↗
• MalfunctionOct 13, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS OPERATING ON A PATIENT WITH VERY DENSE SCLEROTIC BONE. THIS WAS AN INDEX SURGERY. PROPER TECHNIQUE WAS FOLLOWED BUT THE TORQUE REQUIRED TO INSERT AND ADJUST SCREWS WAS INCREDIBLY HIGH. DURING SCREW INSERTION AND ADJUSTMENT SEVERAL SCREW DRIVERS WERE DAMAGED. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) REDUCTION SHAFT. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10672303 ↗