MITEK CRUCIATE+ 219004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705025831), received between Sep 3, 2018 and May 6, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE CRUCIATE+ RETRO REAMER BULLET DEVICE T HANDLE DETACHED FROM THE SHAFT WHILE DRILLING A TUNNEL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968928 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE HANDLE OF THE CRUCIATE+ RETROREAMER BULLET DEVICE CAME OFF DURING REAMING. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819076 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE WHILE USING THE CRUCIATE+ RETROREAMER BULLET, WHEN THE SURGEON PUT THE 4.8 T-HANDLE SHEATH/BULLET ON THE ACL CAPTURE FEMORAL GUIDE(WITH CARRIAGE), TWISTED THE 4.8 T-HANDLE TO RELEASE IT FROM THE ACL CAPTURE FEMORAL GUIDE AND THE TOP OF THE T OF THE 4.8 T-HANDLE FELL OFF RESULTING IN THE T-HANDLE BEING IN TWO PIECES. IT WAS SUGGESTED TO SURGEON TO USE A HEMOSTAT TO GRASP AND TWIST THE 4.8 T-HANDLE LONG PIECE (SHEATH/BULLET PIECE) TO RELEASE IT FROM THE ACL CAPTURE FEMORAL GUIDE. THIS SOLUTION WAS SUCCESSFUL. WE WERE ABLE TO SUCCESSFULLY COMPLETE THE CASE. THE 4.8 T-HANDLE SEPARATED INTO TWO PIECES OUTSIDE THE PATIENT. PATIENT WAS NOT AFFECTED BY THE INSTRUMENT SEPARATION THIS WAS THE FIRST TIME I OR ANYONE ELSE HAS NOTICED ANY DAMAGE TO THE INSTRUMENT. THERE WAS MORE THAN A MINUTE DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711547 ↗
• MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2024 THE CRUCIATE+ RETROREAMER BULLET DEVICE CAME APART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346534 ↗
• MalfunctionSep 3, 2018Separation Failure; Separation Failure

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S CRUCIATE + RETROREAMER WELDED INTO THE BULLET DURING AN ACL PROCEDURE. THE CASE WAS COMPLETED BY REMOVING THE BULLET AND USING ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED. ADDITIONAL INFORMATION RECEIVED ON 8/29/2017 VIA PHONE CALL: THE RETROREAMER GOT STUCK/JAMMED INTO THE BULLET, THERE WERE NO ISSUES WITH MISALIGNMENT OR THE ANGLE. THE DOCTOR DECIDED TO USE ANOTHER BULLET AND RETROREAMER. NO PATIENT CONSEQUENCES, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. ALTERNATIVES WERE READILY AVAILABLE. INFORMATION RECEIVED VIA PHONE FROM OUR SALES REP ON 9-14-2017: THE TWISTR GOT STUCK INTO THE BULLET DURING DRILLING INTO THE JOINT SPACE. THE SURGEON WAS TRYING TO MAKE A BONE TUNNEL, BUT NEVER MADE IT SINCE IT GOT STUCK. NO DAMAGE WAS OBSERVED ON THE RETROREAMER OR THE BULLET PRIOR TO USE. THE BULLET WAS USED AROUND 5 TIMES BEFORE THIS INCIDENT. THIS WAS THE FIRST FAILURE THAT OCCURRED WITH IT. THE BLADE HAD NOT BEEN PREVIOUSLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840669 ↗