BIORCI 7207680Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010459985), received between Oct 4, 2021 and Sep 2, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREADS OF THE BIORCI-HA SCREW BROKE DOWN WHILE SCREWING IN THE 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 20118502 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TIBIAL FIXATION PROCEDURE, THE BIORCI-HA INTERFERENCE SCREW WAS BROKEN. ALL THE PIECES OF THE DEVICE WERE REMOVED FROM THE PATIENT'S BODY USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY 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 18440378 ↗
• MalfunctionOct 4, 2021Break; Break

  IT WAS REPORTED THAT DURING AN LIGAMENTOPLASTY, 3 BIORCI-HA SCREWS BROKE OUTSIDE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572803 ↗