NA 7207030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010252821), received between May 19, 2021 and Aug 18, 2025 — classified as 3 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE THREAD OF THE RCI SCREW WAS DAMAGED, IT CAUSED THE SCREW TO GO INTO THE FEMUR, A C-ARM MACHINE HAD TO BE CALLED. THE SCREW WAS REMOVED USING TWEEZERS AND THERE WAS NO VOID LEFT IN THE PATIENT. SURGERY WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829598 ↗
• InjuryNov 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, WAS FOUND THAT DURING AN ACL PROCEDURE, ONE(1) RCI SCREW HAD AN INADEQUATE FIXATION. IT IS UNKNOWN HOW WAS THE EVENT RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880164 ↗
• InjuryNov 29, 2022Break; Break

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, WAS FOUND THAT DURING AN ACL PROCEDURE, ONE(1) RCI SCREW FAILED AS POSTERIOR BLOW OUT. IT IS UNKNOWN HOW WAS THE EVENT RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880138 ↗
• InjuryMay 19, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A REVISION HAMSTRING TO BTB ACL PATELLA TENDON SURGERY, THE RCI SCREW IN THE FEMUR WAS DIFFICULT WITH REGARD TO OBTAINING A GOOD PULL-IN PURCHASE WITH THE THREADS, BUT THE SCREW IN THE TIBIA SIMPLY PUSHED THE BONE BLOCK THROUGH THE TUNNEL, MAKING THE CONSTRUCT TOO LOOSE ONCE THE SCREW WAS SEATED. THIS RESULTED IN THE NEED TO REMOVE THE SCREW AND RETENTION THE GRAFT, RISKING DAMAGE TO THE GRAFT AS WELL AS THE BONE TUNNEL. THE GRAFT WAS REMOVED FROM THE PATIENT, CHECKED, RE-PREPARED AND THEN RE-IMPLANTED. THIS RESULTED IN THE SUTURES ON THE TIBIA END OF THE GRAFT BREAKING AND NEEDING TO BE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SOFT-SKILL SCREW. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850254 ↗