BIOSURE 72202269Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010622051), received between Nov 27, 2018 and Mar 17, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW FRACTURED. 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 21620674 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE BOLT BROKE DURING THE IMPLEMENTATION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726692 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BIOSURE SCREW WAS BROKEN AT THE FIRST CONTACT WITH THE BONE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358824 ↗
• MalfunctionAug 21, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586420 ↗
• 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 15819665 ↗
• MalfunctionMar 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE SURGEON WAS INSERTING THE BIOSURE PK SCREW IN THE 7.5 MM TIBIAL TUNNEL, THE SCREW THREADED ON ITSELF RENDERING UNUSABLE. ALL ITEMS WERE REMOVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS 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 9822002 ↗
• MalfunctionNov 27, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE IMPLANTING THE DEVICE, THE SCREW BROKE OFF. ALL THE 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 8107992 ↗