MITEK CRUCIATE+ 219003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705025855), received between Jan 30, 2019 and Feb 5, 2024 — classified as 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING SOFT TISSUE ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT WHILE TRYING TO DRILL TIBIAL TUNNEL, THE CRUCIATE+ BEATH PIN BULLET DEVICE WOULD NOT ENGAGE THE CRUCIATE GUIDE CARRIAGE PROPERLY. IT WAS FURTHER REPORTED THAT THE DEVICE MIGHT HAVE BEEN BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639669 ↗
• MalfunctionJul 2, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE FAILURE OF THE CRUCIATE+ BEATH PIN BULLET WAS IDENTIFIED DURING ITS CORRECT USE IN A CADAVEROUS COURSE, THE BEATH PIN 14'', WHICH WAS A PART OF THE DISPOSABLE KIT GOT TRAPPED AND LOCKED INSIDE THE BULLET. WHEN TRYING TO RELEASE IT, THE BULLET WAS BROKEN AND WAS REMAINING IN 2 PARTS IMAGES ATTACHED. BUT STILL THE DRILL DID NOT COME OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756231 ↗
• MalfunctionJan 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE ACR DRILLPN W/EYE AND THE CRUCIATE + BEATH PIN BULLET BECAME STUCK TOGETHER. THE DEVICES BECAME STUCK WHILE DRILLING THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED USING A BACK-UP TRAY. THERE WAS 39-SECOND DELAY IN SURGERY AND NO PATIENT CONSEQUENCE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290072 ↗