BIORCI 7207916Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010000897), received between Sep 1, 2017 and Jul 5, 2023 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL REPAIR, THE BIORCI SCREW 7X20MM WAS USED FOR FEMORAL FIXATION BUT IT WAS NOTICED THAT THE TIP OF THE SCREW WAS BROKEN, THE SCREW WAS REMOVED AND ANOTHER SCREW WAS PLACED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT'S HEALTH WAS NOT AFFECTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260321 ↗
• InjuryDec 27, 2021Break; Break

  IT WAS REPORTED THAT, WHEN TRYING TO PASS THE BIORCI SCRW 7MM THROUGH 8.5MM DIAMETER FEMORAL TUNNEL, THE DEVICE BROKE IN ITS PROXIMAL PART; THEREFORE INSERTION COULD NOT BE COMPLETED. THE BROKEN SCREW WAS COMPLETELY REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087443 ↗
• MalfunctionMar 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE IMPLANT BROKE WHILE BEING INSERTED INTO THE FEMUR. THE PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES 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 9857202 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, TWO BIORCI SCREWS BROKE INTO PIECES WHILE BEING INSERTED INTO THE TUNNEL. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BY USING ARTERY AND GRASPER. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY; ADDITIONAL BONE HOLES DID NOT HAVE TO BE DRILLED. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8748807 ↗
• MalfunctionJul 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, TWO BIORCI SCREWS BROKE INTO PIECES WHILE BEING INSERTED INTO THE TUNNEL. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BY USING ARTERY AND GRASPER. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY; ADDITIONAL BONE HOLES DID NOT HAVE TO BE DRILLED. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8748805 ↗
• MalfunctionFeb 22, 2019Break

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THEY WERE PLACING THE TIBIA SCREW THROUGH THE NITINOL GUIDE, THE SCREW BROKE AND ALL THE BROKEN PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361847 ↗
• MalfunctionDec 10, 2018Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, AT THE MOMENT OF PLACING THE SCREW IN THE FEMORAL TUNNEL, IT BROKE IN HALF WITH THE TIP OF THE SCREW INSIDE THE PATIENT, SO WITH THE HELP OF A TWEEZER, THE REMAINS OF THE SCREW WERE COMPLETELY REMOVED, THIS GENERATED A DELAY AND THE NEED TO PLACE ANOTHER SCREW OF THE SAME REFERENCE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8148456 ↗
• MalfunctionSep 5, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841465 ↗
• MalfunctionSep 1, 2017Break

  IT WAS REPORTED THE TIP OF THE SCREW BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6839937 ↗