BIOSURE 72202260Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010621986), received between Oct 2, 2020 and Jun 5, 2025 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE PEEK 6 X 25MM SCREW WAS LOOSE AND BROKEN. THE DEVICE WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE USED ON THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN PATIENT. THE PATIENT'S HEALTH CONDITION IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150367 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE PK ANCHOR BROKE DURING IMPLANTATION. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. 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 22122661 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT RECONSTRUCTION SURGERY, THE TIP OF THE BIOSURE PK SCREW WAS DEFORMED. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PER THE RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION SHOWS THE DISTAL END OF THE SCREW IS FRACTURED AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293705 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A BIOSURE PK SCREW BROKEN DURING INSERTION; THE BROKEN PIECES WERE REMOVED FROM THE JOINT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE, USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098444 ↗
• InjuryDec 7, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY, IT WAS NOTICED THAT THE BIOSURE WAS USED OUT OF DATE (EXPIRED). THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955256 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW WAS BROKEN WHEN SCREW-IN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. 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 10976732 ↗
• InjuryNov 24, 2020Break; Break

  IT WAS REPORTED THAT DURING A MULTILIGAMENT CASE, THE BIOSURE SCREW DE-THREADED AND A SECTION OF THE TIP STARTED TO PULL AWAY. SURGEON USED A GRASPER AND A SHAVER TO REMOVE BROKEN THREAD FROM THE TIBIAL TUNNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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 10893402 ↗
• MalfunctionOct 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL THE BIOSURE SCATTERED INTO FEW SMALLER PIECES A 1,5 CM OF THE SCREW STAYED INSIDE, IT HAS TO BE RETRIEVED PIECE BY PIECE. A COMPETITOR DEVICES WAS USED IN THE SAME BONE HOLE AND ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY.. 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 Information

  MAUDE report 10623360 ↗