VIPER 286715210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034214009), received between Aug 28, 2017 and Jun 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS CONFIRMED THAT THERE WAS RESIDUAL BLOOD IN THE HOLLOW PORTION OF THE PRODUCTS IN QUESTION. THEY WERE CLEANED AND STERILIZED AGAIN AT THE HOSPITAL FOR USE ON THE FOLLOWING DAY, WEDNESDAY, (B)(6) 2024. THE FACILITY HAS A VERY HIGH LEVEL OF INFECTION AWARENESS. IT IS LIKELY TO AFFECT PRODUCT ADOPTION. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM AWL, CANNULATED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19546606 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE AWL WAS BROKEN. THERE WAS NO KNOWN PATIENT, OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983814 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE AWL WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR AN AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10949279 ↗
• MalfunctionAug 28, 2017Break; Break

  DURING INSPECTION ON (B)(6) 2017 ORTHOKIT SPECIALIST FOUND OUT 2 DEVICES WITH DAMAGE: CODE 286725420, LOT GM3982501 THE INTRODUCTION JAMMED INSERTER GUIDE WIRE SCREW (HOLDER). CODE 286715210, LOT NG41908 BROKE OFF ONE OF THE THREE TEETH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6824488 ↗