BIORCI 7207683Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010460028), received between Jul 28, 2019 and May 22, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE SCR BIORCI-HA SCREW GOT BROKEN WHILE PUTTING IT 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 22070376 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIORCI-HA SCREW GOT BROKEN WHILE PUTTING INTO THE BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 22067335 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW BROKE WHILE THE SCREW WAS GETTING TIGHTENED. THE TIBIAL TUNNEL WAS OF 9 MM MADE WITH A 9 MM TIBIAL REAMER. 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 17022114 ↗
• 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 12572788 ↗
• 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 12572722 ↗
• InjuryMar 22, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY WHILE THE BIORCI SCREW WAS BEING DEPLOYED IT BROKE OFF. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542292 ↗
• MalfunctionJul 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING KNEE SURGERY, THE SCREW BROKE UPON INSERTION. BROKEN PIECES WERE REMOVED SINCE THEY WERE ON THE DRIVER. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834753 ↗