Integra® Jarit® 300SRW253Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780457091), received between Jun 6, 2023 and Jun 6, 2023 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Break; Break

  THE FOLLOWING WAS REPORTED VIA MEDWATCH UF/IMPORTER REPORT #(B)(4): "MORSE RETRACTOR BROKE WHILE BEING USED TO HOLD OPEN PATIENT'S STERNUM. SCREW AND ATTACHMENT PIECE BROKE OFF." ORIGINAL INTENDED PROCEDURE: EMERGENT AORTIC VALVE REPLACEMENT. IT WAS SUBSEQUENTLY REPORTED THAT THE SCREWS AND THE METAL PIECE THAT BROKE OFF FELL INTO THE SURGICAL SITE. THE FRAGMENTS WERE REMOVED BY THE DOCTOR'S HANDS; ALL BROKEN PARTS WERE RECOVERED. AN X-RAY WAS OBTAINED TO ASSURE NO PARTS WERE LEFT IN PATIENT; NO FRAGMENTS WERE FOUND. IT WAS REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THE EVENT. THERE WAS A 5-10 MINUTE DELAY OF SURGERY DUE TO THE PRODUCT PROBLEM. THERE WAS NO INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. STAFF OBTAINED A NEW MORSE RETRACTOR; ONCE ALL PIECES WERE REMOVED, THE SURGEON CONTINUED THE CASE AS NORMAL. IT WAS REPORTED THAT THE DEVICE WAS SENT TO THE FACILITY'S REPROCESSING DEPARTMENT FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076448 ↗