BIORCI 7209016Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010460035), received between Dec 22, 2018 and Sep 16, 2025 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE TIP OF THE BIORCI STERILE SCREW BROKE OFF WHILE INSERTING IT IN THE TIBIAL DRILLED SLOT. THE ARTHROSCOPY WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064437 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE PUTTING THE BIORCI-HA SCREW IN THE TIBIA, IT BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185190 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE SCREW BROKE WHILE FIXATION IN THE TIBIAL. ALL THE SCREW PARTICLES WERE REMOVED FROM THE SITE USING FORCEP. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE USING A TIBIA DRILL BIT TO PREPARE THE INSERTION SITE WITH NO SURGICAL DELAY. NO VOID LEFT IN PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450918 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FRONT PART OF THE BIORCI SCREW BROKE WHEN THE SURGEON INSERTED IT IN THE TIBIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BROKEN PIECES WERE RETRIEVED WITH THE HELP OF TWEEZERS. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401912 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE SCR BIORCI HA SCREW BROKE DURING THE INSERTION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007145 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922109 ↗
• MalfunctionMar 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI HELICOIL SCREW WAS PULLOUT FROM THE BONE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874394 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT DAMAGED WHILE BEING INSERTED IN THE TUNNEL, THE THREADS BROKE. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724544 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE INTO PIECES WHILE INSERTING INTO THE TIBIA TUNNEL. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199747 ↗
• MalfunctionMay 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE THREADS OF THE BIORCI SCREW BROKE WHILE SCREWING IT IN THE TIBIAL TUNNEL. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924885 ↗
• MalfunctionApr 4, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW THREAD WAS SHREDDING DURING THE DEPLOYMENT OF THE SCREW DURING FIXATION. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT, AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676055 ↗
• InjuryFeb 1, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIORCI-HA SCREW COULD NOT ENGAGE AND HENCE WAS TAKEN OUT. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279478 ↗
• InjuryOct 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE HEAD OF THE BIORCI-HA 10X25 STERILE BROKE INSIDE THE PATIENT, DURING FIXATION. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED BY TWEEZER. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616305 ↗
• InjuryJul 22, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT CRACKED. 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 15089723 ↗
• InjuryMay 20, 2021Break; Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION PROCEDURE, THE SCR BIORCI-HA 10X25 STERILE BROKE DURING DEPLOYMENT INTO THE TIBIA. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859190 ↗
• InjuryApr 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE BIORCI SCREW BROKE WHILE IT WAS BEING DEPLOYED. THE BROKEN PIECES WERE REMOVED BY USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11668451 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, INTERNAL TO THE PATIENT, THE TIP OF BIORCI-HA SCREW TIP BROKE IN THE TIBIA. A BACK-UP DEVICE WAS AVAILABLE. IT IS UNKNOWN IF A SIGNIFICANT DELAY OCCURRED. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11593337 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, INTERNAL TO THE PATIENT, THE TIP OF THE BIORCI-HA SCREW BROKE WHILE INSERTING IT IN THE TIBIA. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS 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 11593329 ↗
• InjuryMar 3, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A SURGERY, AFTER THE BIORCI-HA SCREW WAS INSERTED INTO THE BONE TUNNEL AND IT BECAME LOOSE. THE SCREW WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO 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: Unspecified Tissue Injury

  MAUDE report 11408455 ↗
• MalfunctionNov 19, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE SCREW WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. A BACK-UP DEVICE WAS AVAILABLE AND NOT SIGNIFICANT DELAY 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 10871218 ↗
• InjuryOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, WHILE FIXATION THE "BIORCI SCREW-HA (10X25MM)" IN THE TIBIAL TUNNEL, THE TIP OF THE SCREW BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO ADDITIONAL 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 Information

  MAUDE report 10738520 ↗
• MalfunctionMar 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE BIORCI SCREW FAILED. THE SCREW WAS NOT FORWARDING AND WHEN TRIED, THE TIP OF THE SCREW BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO PATIENT INJURY 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 9894759 ↗
• MalfunctionMay 21, 2019Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING SURGERY, SCREW BROKE WHILE DEPLOYING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8628895 ↗
• MalfunctionMar 27, 2019Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE SCREW BROKE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. ALL THE PIECES WERE REMOVED, THE BACK UP DEVICE WAS USED IN THE SAME BONE HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458297 ↗
• MalfunctionDec 22, 2018Break

  IT WAS REPORTED THAT THE HE BIORCI HA SCREW GOT DAMAGED DURING THE SURGERY. NO PATIENT INJURY REPORTED. BACK-UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192893 ↗