BIORCI 7209014Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010460189), received between Dec 14, 2017 and Jan 26, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT AFTER DRILLING THE HOLE AND TRY TO SCREW IN BESIDE THE GRAFT, THE BIORCI SCREW BROKE WHILE INSERTING. SCREW FRAGMENTS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177654 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIORCI SCREW GOT BROKEN WHILE PUTTING INTO THE BONE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727657 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIORCI SCREW TIP GOT BROKEN WHILE PUTTING INTO THE BONE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727613 ↗
• MalfunctionDec 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN WHILE INSERTION AT THE SITE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20996706 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIORCI-HA ANCHOR BROKE DURING DEPLOYMENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291675 ↗
• InjuryOct 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, DURING AN ARTHROSCOPY, THE BIORCI SCREW WAS INSERTED IN THE BONE HOLE AND IT WAS PULLED OUT. SURGERY WAS COMPLETED WITHOUT ANY DELAY, USING A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE FOR THE BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15634205 ↗
• InjuryOct 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW FAILED TO GET ENGAGED & POPPED OUT. THE PROCEDURE WAS SUCCESSFULLY USING A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 15611405 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT BROKE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644999 ↗
• InjuryFeb 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHILE INSERTING A BIORCI-HA SCREW INSIDE THE TUNNEL IT WAS NOT GETTING IN, LATER THE SURGEON FOUND THAT THREADS OF SCREW WERE BROKEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569508 ↗
• InjuryFeb 15, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACLR PROCEDURE, THREE BIORCI SCREWS BROKE INSIDE THE TIBIAL TUNNEL WHEN BEING IMPLANTED. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS AND GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538212 ↗
• InjuryJun 14, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. DUE TO CURRENT WOUNDS IN SCREW INSERTION SITE, THE SCREW WAS REMOVED. IT WAS FOUND THAT NO DEGRADATION OF THE SCREW EVEN AFTER MORE THAN ONE AND A HALF YEAR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury; Unspecified Tissue Injury

  MAUDE report 10151477 ↗
• MalfunctionJul 4, 2019Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION THE SCREW GOT BROKEN INSIDE THE PATIENT'S ANATOMY, ALL THE BROKEN PIECES WERE REMOVED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762788 ↗
• MalfunctionDec 14, 2017Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE SCREW BROKE AT THE TIME OF FIXATION. ALL PARTS WERE REMOVED FROM THE PATIENT AND THERE WAS NO RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119283 ↗