BIORCI 7207564Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010426260), received between Apr 11, 2018 and Jun 25, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A BIORCI SCREW GOT BROKEN EXTERNAL TO THE PATIENT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY; HOWEVER IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196143 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, ONE PATIENT REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING ONE BIORCI SCREW DEVICE. IT IS UNKNOWN HOW WAS THE EVENT TREATED/RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15880189 ↗
• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE "9MM X 30MM 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 12094311 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE BIORCI BROKE OFF WHILE IT WAS BEING INSERTED INTO THE BONE TUNNEL, ALL THE BROKEN PIECES WERE REMOVED USING AN ARTREY INSTRUMENT. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9490114 ↗
• MalfunctionNov 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE BIORCI SCREW BROKE WHILE INSERTING IN THE TIBIA. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, BUT IT IS UNKNOWN IF AN ADDITIONAL BONE HOLE HAD TO BE DRILLED. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT HARMED. 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 9294047 ↗
• MalfunctionJan 22, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE INSERTION, THE SCREW BROKE OFF. PIECES WERE REMOVED FROM PATIENT. BACKUP WAS AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267194 ↗
• MalfunctionAug 6, 2018Break

  IT WAS REPORTED THAT THE SCREW WAS BROKEN DURING PLACING. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS AND THERE WAS NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7752304 ↗
• MalfunctionJun 27, 2018Break

  IT WAS REPORTED A BROKEN SCREW FROM TIP. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642474 ↗
• MalfunctionJun 24, 2018Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632803 ↗
• MalfunctionApr 11, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING A TIBIAL FIXATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7423639 ↗