BIOSURE 72202267Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010621627), received between Mar 20, 2019 and May 29, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE DURING IMPLANTATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333475 ↗
• MalfunctionMay 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A CL PROCEDURE, A BIOSURE PK ANCHOR BODY SPLIT. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062364 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE PEEK INTERFERENCE 8 X 25MM SCREW BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154593 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOUR MONTHS AFTER A LEFT KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2023 USING BIOSURE PK 8 X 25MM SCREWS, ON THE POST-OPERATIVE REVIEW, IT WAS CONCLUDED THAT THE PATIENT RECOVERED WELL, WITH MAGNETIC RESONANCE IMAGING SUGGESTING THAT THE LIGAMENT WAS HEALING WELL. HOWEVER, THE PATIENT DID NOT FOLLOW THE DOCTOR'S ADVICE AND SPRAINED HIS LEFT KNEE AGAIN WHEN PLAYING BASKETBALL ON HIS OWN. THE PATIENT WAS HOSPITALIZED AGAIN ON (B)(6) 2024 FOR ARTHROSCOPIC SURGERY. IT IS UNKNOWN THE OUTCOME OF THE PATIENT.

  Patient problems: Damage to Ligament(s)

  MAUDE report 19337654 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING BIOSURE PK SCREW DEVICES. IT IS UNKNOWN HOW WERE THE EVENTS TREATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15819516 ↗
• InjuryJun 16, 2022Manufacturing, Packaging or Shipping Problem; Missing Information; Manufacturing, Packaging or Shipping Problem; Missing Information

  IT WAS REPORTED THAT DURING A REPAIR OF THE ANTERIOR CRUCIATE LIGAMENT, THE OUTER PACKAGE OF THE BIOSURE ANCHOR WAS FOUND OPENED AND THERE WAS NO BARCODE AND INSTRUCTIONS FOR USE. AS THE PRODUCT WAS A DISPOSABLE PRODUCT, THE SURGEON IMMEDIATELY EXPRESSED DOUBTS AND DID NOT OPEN IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP DEVICE, AND A DELAY OF 40 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14722523 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT BEFORE AN ACL PROCEDURE, THE BIOSURE STERILIZATION PACKAGE PAPER HAD THREE HOLES ON IT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965487 ↗
• InjuryFeb 4, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE BIOSURE PK 8 X 25MM WAS BROKEN IN THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A SMITH AND NEPHEW 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279017 ↗
• MalfunctionMar 20, 2019Peeled/Delaminated

  IT WAS REPORTED THAT THE OUTER LAYER OF THE SCREW PEELED DURING INSERTION AND A REPLACEMENT WAS REQUIRED. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THERE WAS NO LOSS OF TISSUE FIXATION, NO ADDITIONAL BONE HOLE REQUIRED, NO VOID LEFT IN THE PATIENT'S BONE. THE LAYER THAT PEELED OFF WAS REMOVED FROM THE PATIENT WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438348 ↗