BIORCI 7207676Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010459947), received between Jun 20, 2017 and Nov 5, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIORCI HA SCREW TIP GOT BROKEN WHILE IT WAS TAPPING INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, AND THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A TWEEZER. 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 20611116 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN INITIALLY SCREWING THE SCREW IN THE TIBIA IT SNAPPED IN HALF. IT COULD NOT BE KEPT, HALF WAS IN THE PATIENT AND HALF OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356543 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE SCREWING THE BIORCI SCREW, IT BROKE AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061806 ↗
• MalfunctionJan 29, 2020Material Separation; Material Separation

  IT WAS REPORTED ABOUT A SCREW, BIORCI-HA 7/8 X 30 MM THAT DURING AN UNKNOWN PROCEDURE WHILE IT WAS BEING DEPLOYED, THE SCREW GOT BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644225 ↗
• MalfunctionJun 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE BIORCI SCREW BROKE WHILE BEING INSERTED. IT IS UNKNOWN IF THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, BUT IT IS UNKNOWN IF AN ADDITIONAL BONE HOLE HAD TO BE DRILLED TO USE IT. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8733538 ↗
• MalfunctionJun 20, 2017Break

  IT WAS REPORTED THAT DURING INSERTION THE SCREW BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE FOLLOWING A SHORT DELAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6653998 ↗