Integra® Jarit® 121186Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780165071), received between Sep 28, 2022 and Jan 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HEART OPERATION, THE SURGEON NOTICED THAT A PIECE OF THE NEEDLE HOLDER WAS MISSING. BEFORE THE END OF THE OPERATION, AN X-RAY WAS TAKEN. THE MISSING PIECE WAS NOT FOUND IN THE PATIENT'S BODY. MEDICAL STAFF DID NOT KNOW AT WHICH STAGE THE DEVICE BROKE, BUT SUSPECTED IT WAS AT THE BEGINNING OF THE OPERATION. THE EVENT DID NOT LEAD TO PATIENT INJURY, BUT A TWO-HOUR INCREASE IN SURGERY TIME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110119 ↗
• MalfunctionSep 28, 2022Break; Break

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496596 ↗