BIORCI 7207674Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 03596010459916), received between Jan 4, 2018 and Jun 15, 2026 — classified as 16 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (49 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Fracture

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY PROCEDURE, THE TIP OF ONE (1) SCR BIORCI HA SCREW BROKE DURING TIBIAL GRAFT FIXATION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A SIMILAR S+N BACK-UP PRODUCT IN THE SAME BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. THE INSERTION SITE WAS PREPARED USING A GUIDE WIRE AND SCREWDRIVER OF BIORCI-HA, AND IT WAS CONFIRMED THAT THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO ANCHOR INSERTION. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT USING A GRASPER. THE PATIENT IS CURRENTLY IN GOOD CONDITION. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513311 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, BIORCI-HA SCREW GOT CUT WHILE INSERTING IT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678015 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE SCREW BIORCI BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A SIMILAR SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700568 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE TIP OF A BIORCI-HA SCREW BROKE WHILE INSERTING. THE PROCEDURE WAS RESUMED, NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290272 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING AN SN BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22985271 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI-HA SCREW BROKE DURING INSERTION. 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 22984403 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI-HA SCREW BROKE DURING INSERTION. 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 22984258 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE PUTTING IT ON THE TIBIAL SIDE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754344 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) BIORCI-HA SCREW BROKE. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. 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 22710686 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIORCI-HA SCREW GOT BROKEN DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A SURGICAL 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 19981248 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHEN IT WAS BEING TIGHTENING INSIDE THE TIBIA BONE. THE PROCEDURE WAS COMPLETED WITH A S+N 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 19647222 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942338 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIORCI-HA SCREW GOT BROKEN DURING FIXATION. ALL THE BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440266 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIORCI-HA ANCHOR CRUMBLED INTO FRAGMENTS. ALL THE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N 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 18291778 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17724894 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI HA SCREW BROKE INTO PIECES DURING INSERTION IN THE TIBIAL BONE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A DEVICE FROM METAL SCREW IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A REAMER OF 6MM. NO VOID WAS LEFT IN THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT HEALTH STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454685 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN WHILE SCREWING INSIDE THE TIBIAL BONE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158766 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIORCI INTERFERENCE SCREWS BROKE WHEN IT WAS BEING SCREWED INTO THE PATIENT'S TIBIA. 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 16675568 ↗
• InjuryFeb 22, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIORCI-HA SCREW BROKE INSIDE PATIENT. THE BROKEN PIECE WAS REMOVED WITH TWEEZERS, NOTHING WAS LEFT INSIDE THE PATIENT. THE BONE QUALITY WAS REALLY HARD. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. NO ISSUE TO THE PATIENT OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419212 ↗
• InjuryDec 27, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCISCREW GOT BROKEN INTO PIECES WHILE SCREWING IT IN, ALL BROKEN PIECES WERE REMOVED SUCCESSFULLY FROM THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057776 ↗
• InjuryDec 12, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE SCREWING THE BIORCI SCREW IN THE TIBIAL TUNNEL THE TIP OF THE SCREW BROKE. TUNNEL WAS 7MM. THE BROKEN SCREW WAS REMOVED WITH THE HELP OF A DRIVER AND TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964998 ↗
• InjuryNov 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACLR PROCEDURE, THE BIORCI SCREW BROKE WHILE INSERTING INTO THE BONE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860793 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIORCI-HA SCREW BROKE 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 14847342 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING USE, THE BIORCI BROKE WHILE TIGHTENING. 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 14090048 ↗
• InjuryFeb 22, 2022Break; Break

  IT WAS REPORTED THAT, DURING A LIGAMENT REPAIR SURGERY, THE TIP OF A BIORCI-HA SCREW BROKE OFF WHILE PUTTING IT INSIDE THE TIBIAL TUNNEL. THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS AND GRASPERS. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581240 ↗