BIORCI 7207555Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010426192), received between May 4, 2021 and May 4, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Break; Fracture; Defective Device; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE PACKAGE OF THE SCREW BIORCI WAS OPENED, THE THREAD ON TIP WAS FOUND TO BE BROKEN/DEFECTIVE. IT IS UNKNOWN IF THERE WAS A DELAY, IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS ANCHOR WAS FRACTURED AND HAD BIOLOGICAL DEBRIS WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283594 ↗
• InjuryJul 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE BIO-RCI SCREW BROKE OFF. THE PIECE WAS SUCCESSFULLY REMOVED FROM PATIENT WITH TWEEZERS. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166087 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI SCREW BROKE. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098942 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI SCREW BROKE. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098939 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW BROKE. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098933 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE "7X30MM BIORCI SCREW" BROKE. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773818 ↗