Integra® Jarit® P6845TCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780220596), received between Jun 10, 2021 and Jun 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Material Fragmentation; Material Fragmentation

  THIS IS #2 OF 2 REPORTS FOR TWO IDENTICAL DEVICES AND EVENTS. THE FACILITY REPORTED THAT WHEN THE SURGEON WAS DISSECTING TISSUE ON PATIENT NUMBER 2, THE TIP OF REYNOLD SCISSORS NUMBER 2 BROKE ON ONE SIDE OF THE JAW AND FELL INTO THE SURGICAL SITE. ALL THE BROKEN PARTS WERE RECOVERED AND THE FIELD WAS IRRIGATED THOROUGHLY. SUBSEQUENTLY, ANOTHER INSTRUMENT ON THE TRAY IN THE ROOM WAS USED. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972796 ↗
• MalfunctionJun 10, 2021Material Fragmentation; Material Fragmentation

  THIS IS #1 OF 2 REPORTS FOR TWO IDENTICAL DEVICES AND EVENTS. THE FACILITY REPORTED THAT WHEN THE SURGEON WAS DISSECTING TISSUE ON PATIENT NUMBER 1, THE TIP OF REYNOLD SCISSORS NUMBER 1 BROKE ON ONE SIDE OF THE JAW AND FELL INTO THE SURGICAL SITE. ALL THE BROKEN PARTS WERE RECOVERED AND THE FIELD WAS IRRIGATED THOROUGHLY. SUBSEQUENTLY, ANOTHER INSTRUMENT ON THE TRAY IN THE ROOM WAS USED. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972764 ↗