VIPER 279718100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034301389), received between Apr 23, 2018 and Oct 31, 2024 — classified as 6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, QC POLYAXIAL SCREWDRIVER TIP BROKE WHEN INSERTING A SCREW IN LEFT L4 PEDICLE. THE CLOSED POLYAXIAL SCREWDRIVER TIPS BROKE WHEN INSERTING A SCREW IN RIGHT L4 PEDICLE. BOTH TIPS WERE RECOVERED. THERE WAS A 30 MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579085 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION ON AN UNKNOWN DATE IN 2024, THE SCREWDRIVERS BROKE. ALL FRAGMENTS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FORTY-FIVE MINUTES. THIS REPORT IS FOR AN EXP 5.5 CLOSED POLY DRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20026142 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION ON AN UNKNOWN DATE IN 2024, THE SCREWDRIVERS BROKE. ALL FRAGMENTS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FORTY-FIVE MINUTES. THIS REPORT IS FOR AN EXP 5.5 CLOSED POLY DRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20000844 ↗
• MalfunctionJan 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TIP WORN DOWN. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)EXP 5.5 CLOSED POLY DRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428005 ↗
• MalfunctionMar 1, 2019Break; Break

  PRODUCT NAME: T20 CLOSED POLYAXIAL SCREWDRIVER (X2); PRODUCT CODE : 2797-18-100; LOT/BATCH/EXP: GM3752301; DID THE EVENT HAPPEN DURING A PROCEDURE? YES; WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES; WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? YES; EVENT OUTCOME/HOW WAS IT MANAGED? SCREWS WERE EVENTUALLY PLACED USING ANOTHER T20 SCREWDRIVER. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? YES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES- PLEASE NOTE THIS IS LOAN KIT ((B)(4)). PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE SURGEON WAS ATTEMPTING TO PLACE THE SCREWS WITH THE DRIVERS ON THE SACRO-PELVIC SET. AS HE DID THIS, THE DRIVER KEPT SLIPPING IN THE HEAD OF THE SCREW AND FINALLY THE HEAD OF THE SCREW SNAPPED. AFTER PERSISTENCE AND APPLYING GREATER PRESSURE ON THE SCREW WITH ANOTHER DRIVER, THE SCREWS WERE PLACED. IT SHOULD BE HIGHLIGHTED THAT BOTH OF THE DRIVERS ON THE SET CAUSED THIS ISSUE. DURING A PROCEDURE, THE SURGEON HAD GREAT DIFFICULTY PLACING THE SCREWS WITH THESE DRIVERS. PLEASE NOTE THAT THE BONE QUALITY OF THE PATIENT APPEARED TO BE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8382862 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED SCREWDRIVER TIP BROKE IN THE SCREW INTERFACE. WHEN THE SURGEON TRIED TO FINAL TIGHTEN SET SCREW ON THE ROD, THE SET SCREW STRIPPED AND BROKE. WE HAD TO SAW THE HEAD OFF THE SCREW AND THEN USE A UNIVERSAL REMOVAL SET AND A REVERSE THREADED DRIVER TO GET THE ILLIAC SCREW OUT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7452114 ↗