MITEK CRUCIATE+ 219005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705025794), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 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.

• MalfunctionNov 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE CRUCIATE+ 2.4MM BULLET INSERT DEVICE HAD BONE MATTER STUCK IN THE CANNULATED PORTION OF THE DEVICE. THE SALES REP STATED THIS HAPPENED WHILE THE DEVICE WAS BEING REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS UNABLE TO PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103434 ↗