BIOSURE 72202263Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010621610), received between Aug 20, 2019 and Jun 1, 2026 — classified as 2 injuries, 12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25352919 ↗
• MalfunctionDec 30, 2025Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT DURING A CL REPAIR, AFTER THE INSERTION OF THE SCREWS INTO THE BONE CHANNEL USING THE MATCHING GUIDE WIRE, ENSURING THE DIRECTION WAS CORRECT, WHEN ATTEMPTING TO IMPLANT ONE (1) BIOSURE SCREW, THE THREAD CRACKED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED HOLE. NO VOID LEFT. THERE WAS NO FRAGMENTATION LEFT INSIDE THE PATIENT. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923708 ↗
• MalfunctionJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACL SURGERY, THE BIOSURE PK 7 X 25 MMM SCREW FRACTURED WHILE USING IT. THE FRACTURE ANCHOR WAS REMOVED FROM THE PATIENT WITH GRASP AND SCREWDRIVER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED BONE HOLE, LEAVING NO VOID ON THE PATIENT AND CLEARING THE SITE OF INSERTION OF ALL DEBRIS PRIOR THE INSERTION OF THE ANCHOR. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291021 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE PEEK 7 X 25MM SCREW BROKE WHILE BEING IMPLANTED. THE BROKEN SCREW WAS REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144207 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE BIOSURE PK ANCHOR WAS BROKEN AT THE EDGE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY DRILLED 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 22108797 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE BIOSURE SCREW BROKE WHILE BEING IMPLANTED. THE HOLE WAS DRILLED BY THE APPROPRIATE TAP. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE; HOWEVER, IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579154 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE BIOSURE SCREW WAS BROKEN WHEN SCREWING INTO THE FEMUR. ALL THE PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS NO VOID LEFT IN THE PATIENT AND THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A BIOSURE DRIVER AND 1.2MM GUIDE PIN, TUNNEL SIZE 8MM. 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 20206291 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE WHEN SCREWING INTO THE PREPARED CANAL IN THE BONE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043984 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE PK SCREW BROKE INSIDE THE PATIENT; ALL THE BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS A BACK UP AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17796562 ↗
• 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 15819562 ↗
• MalfunctionMay 20, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING THE SET UP FOR AN ARTHROSCOPIC PROCEDURE, THE PACKAGES OF THE 'BIOSURE' SCREWS WERE ALREADY OPEN AND STERILITY WAS AFFECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461571 ↗
• MalfunctionJan 20, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A CL RECONSTRUCTION SURGERY THE BIOSURE HAD A FOREIGN MATTER IN THE PACKAGE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11200780 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE PATIENT´S BONE WAS HARD AND THE SCREW WAS FRACTURED WHEN SCREWED-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 10977137 ↗
• MalfunctionAug 20, 2019Material Separation; Device Dislodged or Dislocated; Material Separation

  IT WAS REPORTED THAT DURING A MPFL PROCEDURE, WHEN THE SURGEON INSERTED THE SCREW TO THE BONE TUNNEL IT WOULDN'T ENGAGE. HE BACKED THE SCREW OUT TO FIND THE TIP HAD CAVED IN. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8909956 ↗