BIORCI 7207566Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010435477), received between Aug 13, 2018 and Feb 4, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryFeb 4, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, AT THE TIME OF PUTTING THE SCREW IN THE TIBIAL TUNNEL IT BROKE. THE REST OF THE SCREW WAS TAKEN OUT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13448389 ↗
• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE "10MM X 25MM BIORCI SCREW" BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094219 ↗
• MalfunctionDec 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, THE BIO RCI BROKE WHILE INSERTING IT INTO THE TIBIAL TUNNEL. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9478584 ↗
• MalfunctionAug 13, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCREW BROKE OFF DURING INSERTION INTO THE TIBIA TUNNEL. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7779084 ↗