VIPER 286760010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034214887), received between Sep 5, 2017 and Aug 16, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE VIPER EXT. TAB KEY HAS A NARROW CANNULATION AND CAN´T PASS THROUGH A GUIDE WIRE 1.37MM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM EXT. TAB POLYAXIAL DRIVER 10MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557376 ↗
• MalfunctionAug 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE VIPER EXT. TAB KEY HAS A NARROW CANNULATION AND CAN´T PASS THROUGH A GUIDE WIRE 1.37MM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM EXT. TAB POLYAXIAL DRIVER 10MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557375 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A PPS IN THE LUMBAR SPINE FOR TREATING TRAUMA ON (B)(6) 2022, WHEN A SCREW WAS ATTACHED TO THE DRIVER, THE DEVICES WERE NOT ALIGNED IN LINE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) POLY DRIVER, 10MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641544 ↗
• MalfunctionOct 22, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS, "IT WAS REPORTED THAT THE TIP OF THE DRIVER THAT ENGAGES WITH THE X-TAB SCREW IS BROKEN OFF. IT IS UNKNOWN HOW THE DAMAGE OCCURRED. THIS WAS DISCOVERED BY THE STERILIZATION DEPARTMENT AFTER SURGERY. "THIS REPORT IS FOR A POLY DRIVER, 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10717682 ↗
• MalfunctionOct 31, 2019Break; Break

  PEDICLE FINDER: THE METAL CORE OF THE HANDLE HAS BEEN MOVED BACKWARDS CAUSING THE AWL TO NOT EXTEND FAR ENOUGH AT THE TIP OF THE ARTICLE. THE SCREWDRIVER: TIP BROKEN OFF MAKING IT IMPOSSIBLE TO SAFELY ATTACH SCREW. REPORTER NAME: (B)(6). POSITION: PRODUKTSPESIALIST SPINE HOSPITAL NAME: (B)(6). DOES THE COMPLAINANT REQUIRE AN OFFICIAL RESPONSE LETTER? NO. WHERE / WHEN DID THE EVENT OCCUR? INTRA - OP. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? NO. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. WAS A PATIENT INVOLVED: NO. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). PEDICLE FINDER CORE (PART#: UNKNOWN, LOT#: MI20051, QUANTITY 1). THIS COMPLIANT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263288 ↗
• MalfunctionApr 25, 2019Break; Break

  IT WAS REPORTED THAT THE X-TAB SCREWDRIVER TIP BROKE OFF DURING MIS TLIF PROCEDURE DONE BY DR (B)(6). X-RAY AND MICROSCOPE WAS USED BY SURGEON TO FIND THE BROKEN METAL PARTS BUT IT COULD NOT BE FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 8550939 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON INSERTED THE SCREW INTO SCLEROTIC BONE AND WIGGLED THE DRIVER CAUSING THE TIP TO SNAP. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8386587 ↗
• MalfunctionSep 5, 2017Break; Break

  TIP OF SCREWDRIVER BROKE OFF, PROCEDURAL STEP IS UNKNOWN, DETAILS HAS NOT BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6842791 ↗