Integra® Jarit® 121145Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780377207), received between Apr 26, 2023 and Apr 26, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 26, 2023Break; Break

  A FACILITY REPORTED THAT DURING THE FINAL STAGES OF THE CASE FOR POSTERIOR COLPOPERINEORRHAPHY WHILE THE SURGEON WAS SUTURING, THE TIP OF THE CARB-BITE MAYO-HEGAR NH 8 (121145) INSERT BROKE OFF INSIDE THE PATIENT. ALL PARTS WERE RECOVERED. THE INTRA-OPERATIVE STAFF WAS ABLE TO OBTAIN ANOTHER NEEDLE DRIVER TO COMPLETE THE CASE. NO PATIENT INJURY OR SURGICAL DELAY OCCURRED. THE FOLLOWING STATEMENT WAS SUBSEQUENTLY REPORTED VIA MEDWATCH (B)(4): "WHILE DR. WAS SUTURING, A FRAGMENT OF METAL WAS NOTICED ON PATIENT'S SKIN. FRAGMENT WAS INSPECTED AND DETERMINED TO BE FROM NEEDLE DRIVERS. THE GRIPPING SURFACE OF THE NEEDLE HOLDER JAWS WAS FRACTURED. SUPERVISOR WAS CONTACTED IMMEDIATELY AND CAME TO OR. THE FRAGMENT AND NEEDLE DRIVER WERE INSPECTED. IT WAS DETERMINED THAT THE FRACTURE WAS A "CLEAN BREAK," AND THERE WERE NO MISSING PIECES. THE SURGICAL TEAM DISCUSSED AND AGREED THAT THERE WAS NO RETAINED METAL AT SURGICAL SITE, AND NO X-RAY WAS NEEDED, PER DR.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820970 ↗