BIORCI 7207682Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 03596010460011), received between Aug 28, 2017 and Apr 16, 2026 — classified as 23 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL, THE TIP OF THE BIORCI HA GOT BROKEN DURING THE INSERTION AT THE TIBIAL SITE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896265 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ACL RECONSTRUCTION, THE SCR BIORCI-HA 9X30 STERILE INTERFERENCE SCREW GOT BROKEN AT THE DISTAL END DURING INSERTION INTO THE TIBIAL TUNNEL, MADE WITH AN 8 MM CANNULATED DRILL. THE PIECES WERE REMOVED FROM PATIENT WITH THE HELP OF ARTERY FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP ON THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622156 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, IT WAS NOTICED THAT A BIORCI-HA SCREW GOT BROKEN DURING DEPLOYMENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361391 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIORCI-HA SCREW'S SIDE STARTED PEELING OFF DURING INSERTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303321 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA 9X30 SCREW BROKE IN BETWEEN WHEN IT WAS SCREWED 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 22176006 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIORCI-HA TIP WAS BROKEN WHILE SCREWING INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, AND THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER. 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 20717399 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIORCI SCREW BROKE WHILE SCREWING INTO THE BONE. ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N 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 20236468 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW TIP BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING 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 20169261 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI HA SCREW HAD A BREAKAGE DURING THE DEPLOYMENT. 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 20151241 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL FIXATION, THE BIORCI-HA SCREW BROKE. A TIBIA DRILL BIT OF 9MM WAS USED FOR PREPARING THE SITE AND THE INSERTION SITE WAS CLEARED BY A SHAVER BLADE BEFORE THE DEPLOYMENT OF THE SCREW. THE SCREW WAS REMOVED WITH FORCEPS AND THERE WAS NO MATERIAL RETAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484664 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW HAD A BREAKAGE DURING DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 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 18912495 ↗
• MalfunctionDec 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA INTERFERENCE SCREW BROKE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298600 ↗
• MalfunctionDec 10, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298598 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA BROKE DURING INSERTION. THE PROCEDURE WAS 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 18182825 ↗
• MalfunctionSep 26, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818826 ↗
• MalfunctionSep 12, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732574 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW DEVICE BROKE WHILE TIGHTENING IN THE TIBIAL TUNNEL. ALL BROKEN PIECES WERE REMOVED FORM PATIENT USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINAL TUNNEL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569438 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHILE TIGHTENING. ALL THE BROKEN PIECES WERE SUCCESSFULLY REMOVED WITH THE HELP OF GRASPER AND TWEEZERS. THE SURGERY WAS COMPLETED AFTER NON-SIGNIFICANT DELAY AND USING A BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A TIBIAL DRILL OF 9MM. NO VOID WAS LEFT IN THE PATIENT, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482375 ↗
• MalfunctionJun 25, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE WHILE BEING INSERTED INTO THE TIBIA. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT BY SUCTION. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOIDS WERE LEFT ON THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196149 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI GOT BROKEN WHILE SCREWING INSIDE THE TIBIAL BONE. THE BROKEN PIECES WERE REMOVED WITH A GRASPER AND TWEEZER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL DRILLED BONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152878 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI ANCHOR BROKE WHILE THE SURGEON WAS SCREWING IT IN. THE PIECES WERE REMOVED WITH HELP OF A TWEEZER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 17022072 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI TIP HAS BROKEN WHILE TIBIAL FIXATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. BONE QUALITY WAS GOOD. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY BONE HOLE, NO VOIDS WERE LEFT IN THE PATIENT. S+N INSTRUMENTS WERE USED TO PREPARE THE INSERTION SITE, INSTRUMENT SIZE: 9MM, TUNNEL SIZE: 9MM. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. PATIENT STATUS IS IN GOOD CONDITION. THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675445 ↗
• InjuryFeb 13, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE BIORCI-HA 9X30 STERILE BROKE WHILST SCREWING INSIDE THE TIBIAL BONE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369516 ↗
• InjuryDec 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE BIORCI-HA SCREW GOT BROKEN WHILE SCREWING IN TO THE BONE, THE BROKEN PIECE WAS REMOVED SUCCESSFULLY BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046044 ↗
• InjuryDec 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIORCISCREW BROKE IN TWO PARTS WHILE TIGHTENING. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929042 ↗