BIORCI 7207568Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010426291), received between Jul 24, 2018 and Jan 31, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A BIORCI SCREW WAS USED TO FIX THE GRAFT IN THE TIBIAL TUNNEL AND WHEN SCREWING IT BROKE; ALL PIECES OF THE BROKEN SCREW WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13401618 ↗
• MalfunctionFeb 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION, AFTER FIXING THE BIORCI 10X35MM SCREW TO THE TIBIA, WHEN THE EXTENDED LEG WAS PLACED, IT WAS NOTICED THAT THE 10X35MM SCREW WAS PASSING WITH DIFFICULTY AND IT BROKE. THE BROKEN SCREW WAS RECOVERED USING A NEEDLE HOLDER AND A SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP BIORCI 10X30MM SCREW INTO THE SAME BONE HOLE. NO PATIENT INJURIES OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 9696314 ↗
• MalfunctionJul 24, 2018Break

  IT WAS REPORTED THAT DURING A REPAIR PROCEDURE, THE SCREW WAS BROKEN IN AN INCOMPLETE LONGITUDINAL WAY, THE GRAFT WAS FIXED WITHOUT ANY PROBLEM IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714672 ↗