BIORCI 7207686Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010459909), received between Dec 20, 2017 and Oct 23, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE PATIENT'S INTERNAL BREAK WAS OBSERVED WHILE INSERTING THE BIOSURE SCREW INTO THE NITINOL WIRE, BUT THIS OCCURRED BEFORE THE SCREW COULD BE SCREWED INTO THE TUNNEL. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, USING A SIMILAR SN BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364515 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE SURGEON USED THE SCREW DRILL TO PLACE THE BIORCI SCREW IN THE FEMUR, THEN THE SPECIALIST WAS ABOUT TO START INSERTING THE SCREW, IT BROKE. THE PROCEDURE WAS 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 16753731 ↗
• InjuryJun 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI HA SCREW BROKE WHILE DEPLOYMENT. THE PIECES WERE RETRIEVED WITH ARTHROSCOPY HHI INSTRUMENT. 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 14750796 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE BIORCI-HA SCREW HAS BROKEN, ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH GRASPERS. THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE IN THE SAME DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462047 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT THE BIORCI SCREW WAS BROKEN DURING INSERTION IN AN ARTHROSCOPY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11070036 ↗
• MalfunctionAug 23, 2018Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION SURGERY, THE SCREW WAS BROKEN WHEN USING. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT, AND A SMITH & NEPHEW BACKUP DEVICE WAS USED TO COMPLETE SUCCESFULLY THE SURGERY WITH NO SIGNIFICANT DELAY. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810760 ↗
• MalfunctionAug 13, 2018Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION SURGERY, THE SCREW BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. A SAME MODEL BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776290 ↗
• MalfunctionDec 20, 2017Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE SCREW BROKE VERTICALLY, ALL PARTS WERE REMOVED FROM THE PATIENT WITHOUT DAMAGE TO THE SAME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133840 ↗