BIORCI 7207561Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010426239), received between Apr 21, 2018 and Dec 12, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE BIORCI SCREW GOT BROKEN WHEN IT WAS BEING PLACED INTO THE TIBIAL BONE. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 20916163 ↗
• InjuryNov 1, 2020Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIORCI ANCHOR BROKE WHILE INSERTING IT INTO TIBIA. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR FURTHER 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 Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10767885 ↗
• MalfunctionApr 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TIBIAL FIXATION THE BIORCI SCREW BROKE WHILE IT WAS SCREWING INTO THE BONE. THE BROKEN PIECE WAS RETRIEVED USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A 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: Foreign Body In Patient

  MAUDE report 9926978 ↗
• MalfunctionAug 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHILE THE SCREW WAS BEING IMPLANTED THE FRONT END BROKE OFF. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932825 ↗
• MalfunctionAug 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHEN THE DEVICE WAS BEING IMPLANTED, THE FRONT END BROKE OFF. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932793 ↗
• MalfunctionAug 5, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE SCREW BROKE, BROKEN PIECES WERE REMOVED USING GRASPERS THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8859417 ↗
• MalfunctionDec 5, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE WHILE TIGHTENING. THERE WAS NOT DELAY ON THE PROCEDURE AND A BACK-UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. UNKNOWN IF THE PIECES WERE RETRIEVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135882 ↗
• MalfunctionOct 4, 2018Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN AT THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935325 ↗
• MalfunctionSep 13, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE WHEN ENTERING THE TUNNEL. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873896 ↗
• MalfunctionSep 13, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE WHEN ENTERING THE TUNNEL. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873882 ↗
• MalfunctionSep 12, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE WHEN ENTERING THE TUNNEL. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7870606 ↗
• MalfunctionJun 29, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649418 ↗
• MalfunctionJun 29, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649416 ↗
• MalfunctionApr 25, 2018Break

  IT WAS REPORTED THAT THE INTERFERENCE SCREW BROKE IN THE FEMORAL TUNNEL AND WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7458603 ↗
• MalfunctionApr 21, 2018Break

  IT WAS REPORTED THAT WHILE ENGAGING THE SCREW IN THE TIBIAL SIDE DURING INSERTION, THE SCREW BROKE AT THE TIP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7449509 ↗