BIORCI 7207679Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 03596010459978), received between Jun 20, 2017 and Oct 15, 2025 — classified as 13 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, IT WAS NOTICED THAT THE HEAD OF THE BIORCI-HA SCREW BROKE AND CAME OUT WHILE THE INSERTION. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290795 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE SCR BIORCI-HA GOT BROKEN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070380 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SCR BIORCI-HA TIP BROKE WHILE BEING INSERTED INTO THE BONE. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068089 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) BIORCI-HA SCREW GOT BROKE WHILE INSERTING IN THE TIBIAL TUNNEL. ALL THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922019 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHEN INSERTING INTO THE TIBIA. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128073 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN WHILE SCREWING INTO THE BONE, THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF TWEEZERS. 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 20356565 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREADS OF THE BIORCI-HA SCREW BROKE DOWN WHILE SCREWING IN THE BONE. 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 20129708 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIORCI SCREW GOT BROKEN WHILE SCREWING INTO THE BONE. ALL BROKEN PIECES WERE RETRIEVED FORM THE PATIENT USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768930 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW 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 18022043 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW 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 18022041 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SCR BIORCI-HA BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684084 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW GOT BROKEN WHILE SCREWING IT INTO THE BONE, BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563886 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE BIORCI SCREW GOT BROKEN WHILE SCREWING INTO THE BONE. ALL BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964774 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE TIGHTENING. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061791 ↗
• InjuryJun 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL, TIBIA SCREW FIXATION PROCEDURE, THE BIOSURE SCREW BROKE OFF WHEN THE SURGEON WAS INSERTING THE SCREW INTO THE TIBIAL TUNNEL. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH BIOSURE DRIVER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750763 ↗
• InjuryMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 'BIORCI' SCREW THREAD BROKE WHILE IMPLANTATION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414774 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT THE SCREW THREADS HAVE BEEN BROKEN WHILE INSERTED IN THE TIBIA. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159838 ↗
• InjuryMar 16, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BIORCI BROKE WHILE TIGHTENING AT TIBIA SIDE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777546 ↗
• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE BIORCI-HA IMPLANT BROKE OFF FOR NO APPARENT REASON. THE IMPLANT DID NOT BREAK INSIDE THE PATIENT AND THERE WAS NO VOID LEFT IN THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666668 ↗
• InjuryJan 25, 2022Break; Break

  IT WAS REPORTED THAT THE BIORCI-HA SCREW BROKE DURING INSERTION. PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341593 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE BIORCI-HA SCREW BROKE. IT IS UNKNOWN IF THE EVENT TOOK PLACE INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290478 ↗
• InjuryJan 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE BIORCI SCREW WAS DAMAGED FROM THE DISTAL END, THEREFORE, IT WAS REMOVED AND PUT ANOTHER SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. UPON INVESTIGATION, IT WAS FOUND THAT BIORCI SCREW WAS FRACTURED, AND THERE WAS DEBRIS IN THE THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192642 ↗
• InjuryJul 28, 2021Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION, THE SCREW BURST. IT IS UNKNOWN IF THERE WAS A DELAY. A SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236039 ↗
• InjuryJul 28, 2021Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION, THE SCREW BURST. IT IS UNKNOWN IF THERE WAS A DELAY. A SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235982 ↗
• InjuryJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN APL PROCEDURE, THE BIORCI SCREW BROKE ON THE THIRD TURN. THE BROKEN PIECES WERE RETRIEVED USING TWEEZERS, PICKUPS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE USING THE SAME BONE HOLE AND NO DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12039756 ↗