BIORCI 7207563Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010426253), received between Apr 18, 2018 and May 3, 2022 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, AN 8.0 TUNNEL WAS MADE WITH A DRILL, THE GRAFT WAS USED AND A 1.5 NITINOL GUIDE WAS USED, BUT AT THE TIME OF ADMISSION THE TIP OF THE BIORCI SCREW BROKE. SURGERY WAS RESUMED WITH A BACK-UP DEVICE, BUT IT IS UNKNOWN WHETHER IT CAUSED OR NOT A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14266089 ↗
• MalfunctionNov 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCR BIORCI 9X25MM WAS BROKEN, IDENTIFIED DURING THE PROCEDURE. NO PATIENT INJURY OR DELAY. S&N BACK-UP DEVICE USED TO COMPLETE THE PROCEDURE. 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 10813739 ↗
• MalfunctionMar 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHILE INSERTING THE BIORCI SCREW INTO THE TIBIAL BONE TUNNEL, IT BROKE. FRAGMENTS WERE REMOVED FROM THE PATIENT USING TWEEZERS. 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 9819679 ↗
• MalfunctionMar 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SCREW WAS PLACED, WHEN IT WAS ARRIVING TO THE LAST THREAD, IT STARTED TO UNFIT. THE SURGEON TRIED TO REMOVE AND IT GOT BROKEN. THE SCREW WAS COMPLETELY REMOVED FROM PATIENT. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE 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 9795351 ↗
• InjuryFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN ACL PROCEDURE ON P2 2016, THE PATIENT HAD PAIN AT THE SITE OF THE KNEE WHERE THE SCREW WAS INSERTED AND AFTER THE PATIENT PRACTICED SPORTS THERE WAS A BUBBLE ON THE INSERTION FILLED WITH LIQUID. THE SCREW WAS PARTIALLY REMOVED AND THE ACTUAL CONDITION OF THE PATIENT IS GOOD, THE PATIENT HAD NORMAL REHAB, AND CAN PRACTICE SPORTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9763975 ↗
• MalfunctionAug 3, 2018Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, BIORCI SCREW WAS BROKEN, BIOSURE SCREW WAS USED INSTEAD OF BIORCI'S ONE. NO PATIENT INJURY WAS REPORTED. THE CASE WAS COMPLETED WITH A NEW BIORCI SCREW. NO ADDITIONAL BONE HOLE REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748356 ↗
• MalfunctionJun 27, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643933 ↗
• MalfunctionApr 18, 2018Break

  IT WAS REPORTED THAT WHILE INSERTING IN TIBIA THE SCREW BROKE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441383 ↗