Integra® Jarit® 121130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780377115), received between Aug 30, 2024 and Aug 30, 2024 — 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.

• MalfunctionAug 30, 2024Break; Break

  IT WAS REPORTED THAT THE NEEDLE DRIVER/CARB-BITE CRILE-WOOD NEEDLEHOLDER 6 (121130) BROKE DURING A FACIAL PROCEDURE. THE TIP BROKE OFF COMPLETELY AND FELL INTO THE SURGICAL SITE. STAFF RETRIEVED THE BROKEN END WITH FORCEPS AND FLUSHED THE SITE. IT WAS REPORTED THAT THE DELAY WAS NOT SIGNIFICANT, LESS THAN 30 MINUTES; JUST LONG ENOUGH TO OPEN A BACK-UP INSTRUMENT. STAFF WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OCCURRED. THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS NOT BEING WEIGHTED OR USED IN ANY ROUGH PROCEDURES AND HAVE BEEN IN USE FOR LESS THAN 2 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112562 ↗