BIORCI 7207677Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03596010459923), received between Jun 20, 2017 and May 25, 2026 — classified as 16 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Break

  IT WAS REPORTED THAT DURING A LET REPAIR PROCEDURE, THE SCREW BIORCI-HA BROKE WHILE INSERTING IN THE TUNNEL. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING SIMILAR S+N BACK UP PRODUCT ON AN ADDITIONAL BONE HOLE USING THE SAME SIZE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25271643 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE BEING INSERTED INTO THE BONE. THE PROCEDURE WAS RESUMED, AFTER A 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 24353677 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN WHILE PUTTING IT INTO THE BONE. THE PROCEDURE WAS COMPLETED USING 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 22074773 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE SCR BIORCI-HA TIP GOT BROKEN WHILE PUTTING INTO THE BONE. 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 22066989 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTRHOSCOPY PROCEDURE,THE SCR BIORCI-HA BROKE, THE BROKEN PIECES WERE REMOVED FROM PATIENT WITH HAND INSTRUMENT. AN ADDITIONAL BONE HOLE WAS NOT NECESSARY. 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 21233804 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW GOT BROKEN WHILE TIGHTENING INSIDE THE TIBIAL 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 19661610 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW TIP WAS FOUND TO BE BROKEN DURING THE FIXATION PROCESS. THE BROKEN PIECES WERE REMOVED USING GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED, PRODUCT WILL RETURN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278876 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE IN THE SAME DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016458 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI HA SCREW BROKE WHILE TIGHTENING. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER AND TWEEZERS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A TIBIAL DRILL OF 7MM. NO VOID WAS LEFT IN THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503251 ↗
• 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 7MM. NO VOID WAS LEFT IN THE PATIENT, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482346 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE INSERTING THE BIORCI-HA SCREW WITH THE SCREW DRIVER, THE SCREW BROKE IN THE MIDDLE. ALL THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT BY SUCTIONS AND A GRASPER. 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 17020083 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT BROKEN WHILE IT WAS TIGHTENED INSIDE THE TIBIAL BONE. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975760 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIORCI INTERFERENCE SCREW 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 16675520 ↗
• InjuryFeb 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI INTERFERENCE SCREW BROKE WHILE IT WAS BEING SCREWED INSIDE THE BONE. ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401580 ↗
• InjuryFeb 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT BROKEN WHILE SCREWING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383777 ↗
• InjurySep 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BIORCI-HA´S SCREW TIP BROKE. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464443 ↗
• InjurySep 2, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI IMPLANT GOT BROKEN WHILE DEPLOYMENT, IMPLANT WAS REMOVED FROM THE PATIENT. 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 15352689 ↗
• InjuryJul 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI HA SCREW GOT BROKEN WHILE TIGHTENING INSIDE THE TIBIA. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983403 ↗
• InjuryMay 18, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE IMPLANTATION. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429592 ↗
• InjuryNov 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BORCI SCREW BROKE WHILE TIGHTENING. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822891 ↗
• InjuryNov 14, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE SCREW BROKE WHILE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808478 ↗
• InjuryAug 4, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE DOWN WHILE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272244 ↗
• 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 12235953 ↗
• InjuryJul 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING IMPLANTATION, THE "7/7 X 30MM BIORCI-HA SCREW" BURST. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214840 ↗
• InjuryJul 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING IMPLANTATION, THE "7/7 X 30MM BIORCI-HA SCREW" BURST. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214324 ↗