Integra® Jarit® 121140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780377177), received between Feb 3, 2020 and Feb 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 3, 2020Detachment of Device or Device Component

  TUNGSTEN CARBIDE INSERT CAME OFF NEEDLE DRIVER. THE PIECE WAS RETRIEVED WITHOUT ISSUE AND THE INSTRUMENT WAS SEQUESTERED FOR CLINICAL ENGINEERING. THE MANUFACTURER HAS BEEN NOTIFIED AND THE DEVICE WILL BE RETURNED UPON REQUEST. NO HARM CAME TO THE PATIENT. MANUFACTURER RESPONSE FOR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE, INTEGRA® JARIT® (PER SITE REPORTER). AWAITING RESPONSE. WE WILL RETURN THE DEVICE FOR FAILURE ANALYSIS IF REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659321 ↗