BIORCI 7207678Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 03596010459961), received between Aug 3, 2017 and May 18, 2026 — classified as 22 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED DURING A KNEE ARTHROSCOPY, ONE (1) BIORCI SCREW GOT BROKEN WHILE INSERTION AT TIBIAL SITE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. 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 25210664 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, ONE (1) BIORCI SCREW BROKE AT THE TIP DURING INSERTION AT SITE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. 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 24887793 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE BIORCI SCREW GOT BROKEN WHILE BEING INSERTED INTO THE BONE. THE BROKEN PIECES WERE REMOVED WITH AN ARTERY AND MOSQUITO FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DE DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. 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 22090555 ↗
• MalfunctionMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, TWO (2) INCIDENTS OF FRACTURE OCCURRED WHEN USING SCR BIORCI-HA 8X25 STERILE, ALL THE PIECES WERE REMOVED FORM PATIENT WITH TWEEZERS. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. A BACK UP DEVICE WAS AVAILABLE AND IT WAS USED ON THE ORIGINALLY DRILLED BONE HOLE MADE WITH A DRILL BIT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054695 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIORCI SCREW BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 1-30 MIN DELAY. ALL THE PIECES WERE REMOVED USING SUCTION. THERE WAS NO VOID LEFT IN THE PATIENT. THE BACK UP DEVICE WAS USED IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357888 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL, WHILE SCREWING A BIOSURE IN THE TIBIAL TUNNEL, ITS THREADS BROKE. 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 20860465 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW TIP BROKE WHILE PUTTING IT INTO THE BONE. 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 20164085 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL, AN BIORCI-HA SCREW GOT BROKEN. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF LESS THAN 30 MINUTES, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924988 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHEN IT WAS INSERTED IN THE TIBIA. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER AND SUCTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A 7MM CANNULATED DRILL. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574303 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA BROKE WHEN IT WAS SCREWING. BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT 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 17288950 ↗
• MalfunctionJun 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE. 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 17243125 ↗
• MalfunctionJun 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI-HA IMPLANT GOT PULLED OUT. THE PROCEDURE WAS 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 17102553 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI TIP GOT BROKEN WHILE SCREWING INTO THE BONE. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965197 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE BIORCI-HA SCREW BROKE WHILE DEPLOYING. THE PROCEDURE WAS COMPLETED WITH 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 16817437 ↗
• InjuryMar 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE TIGHTENING THE BIORCI SCREW THE DEVICE BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616742 ↗
• InjuryDec 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE BIOCI SCREW BROKE DURING INSTALLATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059684 ↗
• InjuryDec 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHILE INSERTION INTO THE TIBIA, ALL THE BROKEN PIECES WERE SUCCESSFULLY REMOVED BY TWEEZERS. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982593 ↗
• InjuryNov 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BIORCI-HA´S SCREW BROKE WHILE BEING DEPLOYED. SURGERY RESUMED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749302 ↗
• InjuryNov 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BIORCI HA´S SCREW BROKE WHILE BEING DEPLOYED. SURGERY RESUMED WITHOUT ANY DELAY WITH A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15747534 ↗
• InjuryOct 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE DISTAL TIP OF THE BIORCI HA SCREW BROKE WHILE IT WAS BEING DEPLOYED IN THE TIBIAL TUNNEL. THE IMPLANT WAS REMOVED SUCCESSFULLY. SURGERY WAS RESUMED 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 15657831 ↗
• InjurySep 8, 2022Break; Break

  IT WAS REPORTED THAT BEFORE AN ACL RECONSTRUCTION SURGERY, ONCE OPENED THE CARTON, IT WAS FOUND THE BIORCISCREW BROKE. THERE WAS A BACK-UP DEVICE AVAILABLE AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382116 ↗
• InjuryAug 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BONE WAS VERY HARD AND WHILE SCREWING THE BIORCI IT BROKE, THEN THE BACK-UP BIORCI ALSO BROKE, THE SURGEON HAD TO INCREASE THE TUNNEL WIDTH AND USE THE THIRD SCREW WHICH WAS SUCCESS. SCREWS WERE REMOVED WITH HELP OF A DRIVER. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE, THE INSTRUMENT USED TO PREPARE THE SITE WAS A TIBIA DRILL OF 8MM, THE INSERTION SITE WAS CLEARED OF ALL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157605 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW TIP GOT BROKEN WHILE SCREWING INTO THE TIBIAL BONE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS 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 15068063 ↗
• InjuryApr 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 'BIORCI SCREW'S' THREADS BROKE WHILE DEPLOYING IT INTO THE TIBIA. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161743 ↗
• InjuryMar 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIORCI SCREW BROKE WHILE SCREWING IT IN THE RIGHT DIRECTION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13754139 ↗