VIPER 286735730Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034214665), received between Feb 1, 2021 and Aug 11, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  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 SPLINTS INSIDE THE ARTICLE WAS GONE, AND IT IS NO LONGER STAYING IN PLACE ON THE REDUCTION DRIVER DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR A THREADED POST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212415 ↗
• MalfunctionMay 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  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 SPLINTS INSIDE THE ARTICLE WAS GONE, AND IT IS NO LONGER STAYING IN PLACE ON THE REDUCTION DRIVER DEVICE. 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 14471295 ↗
• MalfunctionApr 25, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN INSPECTION, IT WAS OBSERVED THAT THE SMALL INNER SPRINGS ON THE IMPLANT INSERTER/EXTRACTOR DEVICE WERE LOOSE; AND THAT THE PEN DID NOT HOLD ON THE SHAFT ANY LONGER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST DEVICE. THIS COMPLAINT INVOLVES 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193090 ↗
• MalfunctionApr 25, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN INSPECTION, IT WAS OBSERVED THAT THE SMALL INNER SPRINGS ON THE IMPLANT INSERTER/EXTRACTOR DEVICE WERE LOOSE; AND THAT THE PEN DID NOT HOLD ON THE SHAFT ANY LONGER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST DEVICE. THIS COMPLAINT INVOLVES 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193087 ↗
• MalfunctionApr 25, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN INSPECTION, IT WAS OBSERVED THAT THE SMALL INNER SPRINGS ON THE IMPLANT INSERTER/EXTRACTOR DEVICE WERE LOOSE; AND THAT THE PEN DID NOT HOLD ON THE SHAFT ANY LONGER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST DEVICE. THIS COMPLAINT INVOLVES 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193086 ↗
• MalfunctionApr 25, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN INSPECTION, IT WAS OBSERVED THAT THE SMALL INNER SPRINGS ON THE IMPLANT INSERTER/EXTRACTOR DEVICE WERE LOOSE; AND THAT THE PEN DID NOT HOLD ON THE SHAFT ANY LONGER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST DEVICE. THIS COMPLAINT INVOLVES 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193085 ↗
• MalfunctionApr 25, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN INSPECTION, IT WAS OBSERVED THAT THE SMALL INNER SPRINGS ON THE IMPLANT INSERTER/EXTRACTOR DEVICE WERE LOOSE; AND THAT THE PEN DID NOT HOLD ON THE SHAFT ANY LONGER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST DEVICE. THIS COMPLAINT INVOLVES 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193082 ↗
• MalfunctionFeb 25, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING KIT INSPECTION ON (B)(6) 2022, TWO THREADED POSTS DID NOT PROPERLY SECURE TO THE THREADED DRIVER. FOR ACCURACY, IT WAS ATTEMPTED WITH MULTIPLE DRIVERS. DIFFERENT THREADED POSTS ON THREADED DRIVERS WERE ALSO ATTEMPTED AND THOSE SECURED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VIPER REDUCTION THREADED POST. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599231 ↗
• MalfunctionFeb 25, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING KIT INSPECTION ON (B)(6) 2022, TWO THREADED POSTS DID NOT PROPERLY SECURE TO THE THREADED DRIVER. FOR ACCURACY, IT WAS ATTEMPTED WITH MULTIPLE DRIVERS. DIFFERENT THREADED POSTS ON THREADED DRIVERS WERE ALSO ATTEMPTED AND THOSE SECURED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VIPER REDUCTION THREADED POST. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599190 ↗
• MalfunctionSep 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING PRE-OP FOR A PROCEDURE, THE EXTENSIONS HAD BEEN CRACKED. THE TIP OF THE POLY DRIVER SHAFT WAS BROKEN AND UNABLE TO ENGAGE INTO THE SCREW. ALSO, THE THREADED POST OF THE X25 DRIVER IS NOT STAYING AND CONTINUES TO SLIDE OFF. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) REDUCTION THREADED POST. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470900 ↗
• 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 THREADED POST 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11414660 ↗
• MalfunctionFeb 1, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) REDUCTION THREADED POSTS WERE LOOSE AND APPEARED TO HAVE LOST THE TIGHT SEAL THEY NORMALLY PROVIDE WHEN PLACED ON THE REDUCTION DRIVERS. THE ISSUE WAS NOTICED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259876 ↗
• MalfunctionFeb 1, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) REDUCTION THREADED POSTS WERE LOOSE AND APPEARED TO HAVE LOST THE TIGHT SEAL THEY NORMALLY PROVIDE WHEN PLACED ON THE REDUCTION DRIVERS. THE ISSUE WAS NOTICED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST. THIS IS REPORT 2 OF 4 FOR (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259861 ↗
• MalfunctionFeb 1, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) REDUCTION THREADED POSTS WERE LOOSE AND APPEARED TO HAVE LOST THE TIGHT SEAL THEY NORMALLY PROVIDE WHEN PLACED ON THE REDUCTION DRIVERS. THE ISSUE WAS NOTICED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259853 ↗
• MalfunctionFeb 1, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) REDUCTION THREADED POSTS WERE LOOSE AND APPEARED TO HAVE LOST THE TIGHT SEAL THEY NORMALLY PROVIDE WHEN PLACED ON THE REDUCTION DRIVERS. THE ISSUE WAS NOTICED DURING TRAINING. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) REDUCTION THREADED POST. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259800 ↗