Integra® Jarit® 280405Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780385783), received between May 7, 2023 and Sep 2, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568822 ↗
• InjuryMar 21, 2025Break; Break

  THE FOLLOWING WAS REPORTED VIA MEDWATCH REPORT# MW5165904: "A 2MM PITUITARY RONGEUR BROKE WHILE IN USE, WORKING END TIP BROKE OFF INTO DISC SPACE. USING X-RAY TO IDENTIFY THE LOCATION, REMOVAL WAS ATTEMPTED. PIECE WAS UNABLE TO BE REMOVED." IT WAS SUBSEQUENTLY REPORTED THAT THERE WAS A DELAY IN SURGERY GREATER THAN 15 MINUTES. THE SURGERY WAS "COMPLETED WITH THE ADDITION OF ATTEMPTED REMOVAL UTILIZING X-RAY WHICH WAS UNSUCCESSFUL". IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21670878 ↗
• MalfunctionMay 7, 2023Difficult to Open or Close; Difficult to Open or Close

  A FACILITY REPORTED THAT DURING SURGERY, THE CUSHING RONGUER 7 2X10MM STR (280405) WAS NOT BITING/CLOSING PROPERLY; THE UPPER AND LOWER JAW WERE NOT TOUCHING OR CUTTING PROPERLY. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS AN ESTIMATED 30-MINUTE INCREASE IN SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883840 ↗